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国立がん研究センター「がんムーンショットバイオバンク」

2026年10月2日 更新者：National Cancer Institute (NCI)

がんムーンショット バイオバンク研究プロトコル

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

1600

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

13年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patients undergoing treatment for cancer types with commercially available therapies.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
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.
手順：Computed Tomography

Undergo CT

他の名前：
  • CT
  • 猫
  • CATスキャン
  • コンピューター断層撮影
  • コンピュータ化されたアキシャルトモグラフィー
  • CTスキャン
  • トモグラフィー
  • コンピューター断層撮影 (手順)
  • コンピューター断層撮影 (CT) スキャン
  • 診断CATスキャン
  • 診断CATスキャンサービスタイプ
手順：Magnetic Resonance Imaging

Undergo MRI

他の名前：
  • MRI
  • 磁気共鳴
  • 磁気共鳴画像スキャン
  • 医用画像、磁気共鳴 / 核磁気共鳴
  • 氏
  • MRイメージング
  • MRI スキャン
  • NMRイメージング
  • NMRI
  • 核磁気共鳴イメージング
  • 磁気共鳴画像法 (MRI)
  • sMRI
  • 磁気共鳴画像法（手順）
  • 構造MRI
手順：Positron Emission Tomography

Undergo PET/CT

他の名前：
  • 医用画像、陽電子放出断層撮影
  • ペット
  • PETスキャン
  • 陽電子放出断層撮影スキャン
  • 陽電子放出断層撮影
  • PT
  • 陽電子放出断層撮影（手順）
手順：Biospecimen Collection

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

他の名前：
  • 生物学的サンプルの収集
  • 採取された生体試料
  • 標本収集
  • サンプル収集
他の：Medical Chart Review

Medical charts are reviewed and data is collected

他の名前：
  • チャートレビュー
手順：Paracentesis

Undergo paracentesis

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Procure, store and distribute longitudinal biospecimens and associated clinical data
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of minority and underserved study participants accrued
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

National Cancer Institute (NCI)

捜査官

  • 主任研究者：Lyndsay N Harris、National Cancer Institute (NCI)

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年11月11日

一次修了 (推定)

2027年4月30日

研究の完了 (推定)

2027年4月30日

試験登録日

最初に提出

2020年3月18日

QC基準を満たした最初の提出物

2020年3月18日

最初の投稿 (実際)

2020年3月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月5日

QC基準を満たした最後の更新が送信されました

2026年10月2日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • NCI-2020-00750
  • NCI-2020-00750 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
  • 10323 (その他の識別子：CTEP)
  • 10323 (その他の識別子：Division of Cancer Treatment and Diagnosis)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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