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National Cancer Institute "Cancer Moonshot Biobank"

2 oktober 2026 uppdaterad av: National Cancer Institute (NCI)

Cancer Moonshot Biobank Research Protocol

This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVE:

I. To support current and future investigations into drug resistance and sensitivity and other National Cancer Institute (NCI)-sponsored cancer research initiatives through the procurement and distribution of multiple longitudinal biospecimens and associated data from a diverse group of cancer patients who are undergoing standard of care treatment at NCI Community Oncology Research Program (NCORP) sites and other National Clinical Trials Network (NCTN) sites.

SECONDARY OBJECTIVES:

I. To provide a service of value to study participants and their medical providers through the performance of molecular profiling assays on tumor samples in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory and reporting of results to physicians and patients that they may opt to use in clinical management, including analysis of data for acquired resistance mechanisms.

II. To enable the development of patient-derived models such as cell lines and xenografts for cancer researchers through the provision of biospecimens from up to 20% of study participants to the NCI's Patient Derived Models Repository (PDMR), a national resource available to investigators.

III. To develop and implement robust approaches in patient and provider engagement to improve understanding of biobanking and its relationship to cancer research and increase representation of minority and underserved study participants in cancer research.

IV. To develop increased capabilities in United States (U.S.) community hospitals and clinics for contribution to cancer research through biobanking activities.

V. To enable secondary research generated from the project through deposition of data in public repositories such as Cancer Research Data Commons (CRDC), The Cancer Imaging Archive (TCIA) and database of Genotypes and Phenotypes (dbGaP) and other potential NCI databases, including clinical, radiology and pathology data with an emphasis on treatment response and outcome data.

VI. To provide residual biospecimens and associated data from the project to the cancer research community.

OUTLINE:

Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected if available. Additionally, patients may undergo computed tomography (CT), positron emission tomography (PET)/CT and/or magnetic resonance imaging (MRI) throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.

Studietyp

Observationell

Inskrivning (Beräknad)

1600

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Daphne, Alabama, Förenta staterna, 36526
        • Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
      • Fairhope, Alabama, Förenta staterna, 36532
        • Thomas Hospital
      • Mobile, Alabama, Förenta staterna, 36607
        • Mobile Infirmary Medical Center
      • Saraland, Alabama, Förenta staterna, 36571
        • Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
    • Arizona
      • Kingman, Arizona, Förenta staterna, 86401
        • Kingman Regional Medical Center
    • Arkansas
      • Fort Smith, Arkansas, Förenta staterna, 72903
        • Mercy Hospital Fort Smith
    • California
      • Arroyo Grande, California, Förenta staterna, 93420
        • PCR Oncology
      • Bakersfield, California, Förenta staterna, 93301
        • AIS Cancer Center at San Joaquin Community Hospital
      • Loma Linda, California, Förenta staterna, 92357
        • Veterans Affairs Loma Linda Healthcare System
      • Salinas, California, Förenta staterna, 93901
        • Salinas Valley Memorial
    • Colorado
      • Brighton, Colorado, Förenta staterna, 80601
        • Intermountain Health Platte Valley Hospital
      • Denver, Colorado, Förenta staterna, 80218
        • Saint Joseph Hospital - Cancer Centers of Colorado
      • Golden, Colorado, Förenta staterna, 80401
        • Lutheran Hospital - Cancer Centers of Colorado
      • Grand Junction, Colorado, Förenta staterna, 81501
        • Saint Mary's Hospital and Regional Medical Center
      • Lafayette, Colorado, Förenta staterna, 80026
        • Good Samaritan Hospital - Cancer Centers of Colorado
    • Connecticut
      • Hartford, Connecticut, Förenta staterna, 06102
        • Hartford Hospital
    • Delaware
      • Dover, Delaware, Förenta staterna, 19901
        • Bayhealth Hospital Kent Campus
      • Milford, Delaware, Förenta staterna, 19963
        • Bayhealth Hospital Sussex Campus
    • Florida
      • Boca Raton, Florida, Förenta staterna, 33486
        • Boca Raton Regional Hospital
      • Deerfield Beach, Florida, Förenta staterna, 33064
        • Broward Health North
      • Fort Lauderdale, Florida, Förenta staterna, 33316
        • Broward Health Medical Center
      • Tampa, Florida, Förenta staterna, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30342
        • Northside Hospital
      • Savannah, Georgia, Förenta staterna, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Illinois
      • Bloomington, Illinois, Förenta staterna, 61704
        • Illinois CancerCare-Bloomington
      • Chicago, Illinois, Förenta staterna, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, Förenta staterna, 60625
        • Swedish Covenant Hospital
      • Danville, Illinois, Förenta staterna, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, Förenta staterna, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Förenta staterna, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Evanston, Illinois, Förenta staterna, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Förenta staterna, 61401
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, Förenta staterna, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, Förenta staterna, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Mattoon, Illinois, Förenta staterna, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Mount Vernon, Illinois, Förenta staterna, 62864
        • SSM Health Good Samaritan
      • Pekin, Illinois, Förenta staterna, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, Förenta staterna, 61615
        • Illinois CancerCare-Peoria
      • Urbana, Illinois, Förenta staterna, 61801
        • Carle Cancer Center
      • Washington, Illinois, Förenta staterna, 61571
        • Illinois CancerCare - Washington
    • Iowa
      • Ames, Iowa, Förenta staterna, 50010
        • McFarland Clinic - Ames
      • Bettendorf, Iowa, Förenta staterna, 52722
        • University of Iowa Healthcare Cancer Services Quad Cities
      • Cedar Rapids, Iowa, Förenta staterna, 52403
        • Oncology Associates at Mercy Medical Center
      • Cedar Rapids, Iowa, Förenta staterna, 52402
        • Physicians' Clinic of Iowa PC
      • Des Moines, Iowa, Förenta staterna, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Förenta staterna, 50309
        • Blank Children's Hospital
      • Des Moines, Iowa, Förenta staterna, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Iowa City, Iowa, Förenta staterna, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, Förenta staterna, 70808
        • Our Lady of the Lake Physician Group
      • New Orleans, Louisiana, Förenta staterna, 70118
        • Children's Hospital New Orleans
      • New Orleans, Louisiana, Förenta staterna, 70112
        • University Medical Center New Orleans
      • Shreveport, Louisiana, Förenta staterna, 71103
        • LSU Health Sciences Center at Shreveport
    • Maine
      • Augusta, Maine, Förenta staterna, 04330
        • Harold Alfond Center for Cancer Care
      • Belfast, Maine, Förenta staterna, 04915
        • MaineHealth Waldo Hospital
      • Biddeford, Maine, Förenta staterna, 04005
        • MaineHealth Maine Medical Center - Biddeford
      • Brunswick, Maine, Förenta staterna, 04011
        • MaineHealth Cancer Care and IV Therapy - Brunswick
      • Brunswick, Maine, Förenta staterna, 04011
        • Mid Coast Hospital
      • Damariscotta, Maine, Förenta staterna, 04543
        • MaineHealth LincolnHealth Hospital
      • Farmington, Maine, Förenta staterna, 04938
        • MaineHealth Franklin Hospital
      • Lewiston, Maine, Förenta staterna, 04240
        • Saint Mary's Regional Medical Center
      • Norway, Maine, Förenta staterna, 04268
        • MaineHealth Stephens Hospital
      • Portland, Maine, Förenta staterna, 04102
        • Maine Medical Partners Surgical Care
      • Portland, Maine, Förenta staterna, 04102
        • MMP Surgical Care Casco Bay
      • Portland, Maine, Förenta staterna, 04102
        • MaineHealth Maine Medical Center - Portland
      • Rockport, Maine, Förenta staterna, 04856
        • Penobscot Bay Medical Center
      • Sanford, Maine, Förenta staterna, 04073
        • MaineHealth Cancer Care and IV Therapy - Sanford
      • Scarborough, Maine, Förenta staterna, 04074
        • Maine Children's Cancer Program
      • Scarborough, Maine, Förenta staterna, 04074
        • MaineHealth Maine Medical Center- Scarborough
      • South Portland, Maine, Förenta staterna, 04106
        • MaineHealth Cancer Care and IV Therapy - South Portland
      • South Portland, Maine, Förenta staterna, 04106
        • MaineHealth Urology - South Portland
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, Förenta staterna, 48114
        • Trinity Health Medical Center - Brighton
      • Canton, Michigan, Förenta staterna, 48188
        • Trinity Health Medical Center - Canton
      • Chelsea, Michigan, Förenta staterna, 48118
        • Chelsea Hospital
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Iron Mountain, Michigan, Förenta staterna, 49801
        • Dickinson County Healthcare System
      • Livonia, Michigan, Förenta staterna, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Pontiac, Michigan, Förenta staterna, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
    • Missouri
      • Ballwin, Missouri, Förenta staterna, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Joplin, Missouri, Förenta staterna, 64804
        • Freeman Health System
      • Joplin, Missouri, Förenta staterna, 64804
        • Mercy Hospital Joplin
      • Rolla, Missouri, Förenta staterna, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Förenta staterna, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Förenta staterna, 64506
        • Heartland Regional Medical Center
      • Springfield, Missouri, Förenta staterna, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Förenta staterna, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Förenta staterna, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Förenta staterna, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Förenta staterna, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Förenta staterna, 63128
        • Mercy Hospital South
      • Washington, Missouri, Förenta staterna, 63090
        • Mercy Hospital Washington
    • Montana
      • Billings, Montana, Förenta staterna, 59102
        • Saint Vincent Frontier Cancer Center
      • Butte, Montana, Förenta staterna, 59701
        • Saint James Community Hospital and Cancer Treatment Center
    • Nebraska
      • Grand Island, Nebraska, Förenta staterna, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
    • Nevada
      • Carson City, Nevada, Förenta staterna, 89703
        • Carson Tahoe Regional Medical Center
      • Las Vegas, Nevada, Förenta staterna, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Förenta staterna, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Förenta staterna, 89144
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, Förenta staterna, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Förenta staterna, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Förenta staterna, 89103
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, Förenta staterna, 89183
        • OptumCare Cancer Care at Fort Apache
    • New Hampshire
      • Nashua, New Hampshire, Förenta staterna, 03060
        • Saint Joseph Hospital
    • New Jersey
      • Morristown, New Jersey, Förenta staterna, 07960
        • Morristown Medical Center
      • Newton, New Jersey, Förenta staterna, 07860
        • Newton Medical Center
      • Pompton, New Jersey, Förenta staterna, 07444
        • Chilton Medical Center
      • Summit, New Jersey, Förenta staterna, 07902
        • Overlook Hospital
    • New York
      • New York, New York, Förenta staterna, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • The Bronx, New York, Förenta staterna, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, Förenta staterna, 10467
        • Children's Hospital at Montefiore
      • The Bronx, New York, Förenta staterna, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, Förenta staterna, 10461
        • Montefiore Medical Center-Weiler Hospital
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28204
        • Novant Health Presbyterian Medical Center
      • Greenville, North Carolina, Förenta staterna, 27834
        • East Carolina University
      • Greenville, North Carolina, Förenta staterna, 27834
        • ECU Health Medical Center
      • Kernersville, North Carolina, Förenta staterna, 27284
        • Novant Health Cancer Institute - Kernersville
      • Kinston, North Carolina, Förenta staterna, 28501
        • ECU Health Oncology Kinston
      • Mount Airy, North Carolina, Förenta staterna, 27030
        • Novant Health Cancer Institute - Mount Airy
      • Pinehurst, North Carolina, Förenta staterna, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
      • Thomasville, North Carolina, Förenta staterna, 27360
        • Novant Health Cancer Institute - Thomasville
      • Washington, North Carolina, Förenta staterna, 27889
        • Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
      • Winston-Salem, North Carolina, Förenta staterna, 27103
        • Novant Health Forsyth Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73120
        • Mercy Hospital Oklahoma City
    • Rhode Island
      • Providence, Rhode Island, Förenta staterna, 02908
        • Roger Williams Medical Center
    • South Carolina
      • Columbia, South Carolina, Förenta staterna, 29203
        • Prisma Health Richland Hospital
      • Columbia, South Carolina, Förenta staterna, 29220
        • Prisma Health Baptist Hospital
      • Gaffney, South Carolina, Förenta staterna, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, Förenta staterna, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greer, South Carolina, Förenta staterna, 29651
        • Gibbs Cancer Center-Pelham
      • Spartanburg, South Carolina, Förenta staterna, 29303
        • Spartanburg Medical Center
      • Union, South Carolina, Förenta staterna, 29379
        • SMC Center for Hematology Oncology Union
    • Texas
      • San Antonio, Texas, Förenta staterna, 78229
        • Audie L Murphy VA Hospital
    • Virginia
      • Lynchburg, Virginia, Förenta staterna, 24501
        • Centra Alan B Pearson Regional Cancer Center
      • Richmond, Virginia, Förenta staterna, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, Förenta staterna, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Renton, Washington, Förenta staterna, 98055
        • Valley Medical Center
      • Yakima, Washington, Förenta staterna, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • West Virginia
      • Huntington, West Virginia, Förenta staterna, 25701
        • Edwards Comprehensive Cancer Center
      • Morgantown, West Virginia, Förenta staterna, 26505
        • Monongalia Hospital
    • Wisconsin
      • Eau Claire, Wisconsin, Förenta staterna, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Marshfield, Wisconsin, Förenta staterna, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, Förenta staterna, 53215
        • Aurora Saint Luke's Medical Center
      • Minocqua, Wisconsin, Förenta staterna, 54548
        • Marshfield Medical Center - Minocqua
      • Rice Lake, Wisconsin, Förenta staterna, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, Förenta staterna, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Weston, Wisconsin, Förenta staterna, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • San Juan Community Oncology Group
      • San Juan, Puerto Rico, 00927
        • Centro Comprensivo de Cancer de UPR
      • San Juan, Puerto Rico, 00936
        • San Juan City Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

13 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients undergoing treatment for cancer types with commercially available therapies.

Beskrivning

Inclusion Criteria:

  • Is consistent with OR has been diagnosed with one of the following:

    • Colorectal cancer: stage IV

    • Non-small cell or small cell lung cancer: stage III/IV

    • Prostate cancer: metastatic prostate cancer

    • Gastric cancer, not otherwise specified (NOS): stage IV

    • Esophageal cancer, NOS: stage IV

    • Adenocarcinoma of gastroesophageal junction: stage IV

    • High grade serous ovarian cancer: stage III/IV

    • Invasive breast carcinoma: stage III/IV

    • Melanoma: stage III/IV

    • Acute myeloid leukemia

    • Multiple myeloma

      • For the purposes of this study,

        • Re-staging is allowed
        • Having more than one primary cancer is allowed, if the patient is being treated solely for one of the eligible cancers listed above

  • Patient should fit in one of the following four clinical scenarios (a-d)

    • Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR
    • Scheduled to begin treatment with a new regimen of standard of care therapy OR
    • Currently progressing on a regimen of standard of care therapy OR
    • Currently being treated with a regimen standard of care therapy, without evidence of progression

  • Requirements for fresh tissue biospecimen collections at enrollment:

    • For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment

      • For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy

      • For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure

      • For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR

      • The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling

        • Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state

  • Requirements for archival tissue:

    • For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE

    • For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED

    • Pre-existing archival material (formalin-fixed, paraffin-embedded [FFPE] block, BM aspirate, or unstained slides) that:

      • Contains the cancer type for which the participant is enrolled, and
      • Was collected no more than 5 years prior to initiation of therapy, and
      • Contains at least a surface area of 5 mm^2 and optimal surface area of 25 mm^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and
      • Contains at least 10% tumor content. 70% tumor content is optimal, and
      • No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy

  • Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment

    • Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection
    • Blood collection for clinical scenario d must take place within 4 weeks of enrollment, and while patient is on treatment

  • Age 13 or older

  • Any sex

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2

  • Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)

  • NCI PDMR INCLUSION CRITERIA: Patients with CRC with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status

  • NCI PDMR INCLUSION CRITERIA: Patients with CRC who are 40 years old or younger at time of collection irrespective of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status

  • NCI PDMR INCLUSION CRITERIA: Patients with BRCA that are either

    • Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+)
    • African American with triple negative (ER-PR-HER2-)

  • NCI PDMR INCLUSION CRITERIA: Patients with lung cancer (LCA), prostate cancer (PCA), gastroesophageal cancer (GEC), ovarian cancer (OV), acute myeloid leukemia (AML), multiple myeloma (MML)

Exclusion Criteria:

  • Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial

    • For the purposes of this study, past enrollment in clinical trials whereby the patient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed

  • Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy

  • Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion

    • Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use

    • Factor X inhibitors are permitted

    • Use of anti-platelet drugs are permitted

      • Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP)

  • NCI PDMR EXCLUSION CRITERIA: Patients with complete response

  • NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections

  • NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection

    • Actively febrile patients with uncertain etiology of febrile episode
    • All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection
    • No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics

  • NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) or known history of HBV/HCV without documented resolution

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Observational (biospecimen collection, chart review)

Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected if available. Additionally, patients may undergo CT, PET/CT and/or MRI throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Procedur: Computed Tomography

Undergo CT

Andra namn:
  • CT
  • KATT
  • Datortomografi
  • Beräknad axiell tomografi
  • Datoriserad axialtomografi
  • tomografi
  • Datoriserad axiell tomografi (förfarande)
  • Datortomografi (CT) skanning
  • Diagnostisk kattskanning
  • Diagnostisk kattskanningstjänsttyp
Procedur: Magnetic Resonance Imaging

Undergo MRI

Andra namn:
  • MRI
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
  • HERR
  • MR-avbildning
  • MRI-skanning
  • NMR-avbildning
  • NMRI
  • Kärnmagnetisk resonanstomografi
  • Magnetisk resonanstomografi (MRT)
  • sMRI
  • Magnetisk resonanstomografi (förfarande)
  • Strukturell MRI
Procedur: Positron Emission Tomography

Undergo PET/CT

Andra namn:
  • Medicinsk avbildning, Positron Emission Tomografi
  • SÄLLSKAPSDJUR
  • Djur Scan
  • Positron Emission Tomography Scan
  • Positronemissionstomografi
  • PT
  • Positronemissionstomografi (förfarande)
Procedur: Biospecimen Collection

Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Övrig: Medical Chart Review

Medical charts are reviewed and data is collected

Andra namn:
  • Kartgranskning
Procedur: Paracentesis

Undergo paracentesis

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Procure, store and distribute longitudinal biospecimens and associated clinical data
Tidsram: Up to 10 years

Will procure, store and distribute longitudinal biospecimens and associated clinical data for current and future cancer research in order to elucidate molecular mechanisms of sensitivity and intrinsic or acquired resistance to standard of care systemic therapies, including immunotherapy. Cases will be grouped according to patient demographics, cancer type and treatment regimen. Statistical analysis will be descriptive and will be analyzed for each Biospecimen Source Site (BSS) as well as study aggregate.
Up to 10 years
Percentage of enrolled patients by cancer type and treatment regimen overall
Tidsram: Until completion of biospecimen collection, up to 3 years

Will assess the percentage of enrolled patients by cancer type and treatment regimen overall and those who contribute samples to the Drug Resistance and Sensitivity Network and other approved investigators. Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Until completion of biospecimen collection, up to 3 years
Percentage of minority and underserved study participants accrued
Tidsram: Until completion of biospecimen collection, up to 3 years

Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Until completion of biospecimen collection, up to 3 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of minority and underserved study participants accrued
Tidsram: Until completion of biospecimen collection, up to 3 years

Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Until completion of biospecimen collection, up to 3 years
Pan-cancer gene panel tumor next generation sequencing test
Tidsram: Until completion of biospecimen collection, up to 3 years

Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Until completion of biospecimen collection, up to 3 years
Cancer Research Data Commons, The Cancer Imaging Archive and database of Genotypes and Phenotypes data contribution
Tidsram: Until completion of biospecimen collection, up to 3 years

Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom molecular profiling is attempted
Tidsram: Until completion of biospecimen collection, up to 3 years

Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom molecular profiling results are generated
Tidsram: Until completion of biospecimen collection, up to 3 years

Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom samples are obtained at each longitudinal timepoint
Tidsram: Until completion of biospecimen collection, up to 3 years

Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Until completion of biospecimen collection, up to 3 years
Percentage of collected biospecimens that are delivered to the Patient Derived Models Repository
Tidsram: Until completion of biospecimen collection, up to 3 years

Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Until completion of biospecimen collection, up to 3 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Lyndsay N Harris, National Cancer Institute (NCI)

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 november 2020

Primärt slutförande (Beräknad)

30 april 2027

Avslutad studie (Beräknad)

30 april 2027

Studieregistreringsdatum

Först inskickad

18 mars 2020

Först inskickad som uppfyllde QC-kriterierna

18 mars 2020

Första postat (Faktisk)

19 mars 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCI-2020-00750
  • NCI-2020-00750 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • 10323 (Annan identifierare: CTEP)
  • 10323 (Annan identifierare: Division of Cancer Treatment and Diagnosis)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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