Indsamling af blod fra patienter med kræft
Bioprøveoptagelse fra menneskelige forsøgspersoner
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.
Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Background:
- Correlative studies performed on biospecimens of human subjects can be used to investigate the biology of solid tumors, inform the development of new strategies for treating those cancers, and evaluate these new therapeutic approaches. Specific areas of interest include, but are not limited to:
- the underlying mechanisms of tumor-specific immune response and suppression in cancer patients
- genetic and molecular profiling of tumors through circulating tumor cell (cTC), circulating DNA, and tissue analysis
- investigation of potential early diagnostic and prognostic indicators for solid tumors such as cTCs and miRNA expression of serum exosomes
- identification of mechanisms of drug-related adverse events and correlation with clinical parameters
- the role of commensal gut microbiota in both the innate and adaptive responses to tumors as well as with the use of anticancer agents
Objectives:
- Analyze biospecimens such as tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
- Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
- Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Eligibility:
- Patients and healthy volunteers whose biospecimens are of interest to NIH investigators.
- 18 years of age or older.
Design:
- Cases will be evaluated by NCI or Interventional Radiology, NIH Clinical Center personnel. Blood, tissue, urine, saliva or other samples may be collected at the initial visit and at follow-up visits.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Jennifer L Marte
- Telefonnummer: (301) 496-7214
- E-mail: martej@mail.nih.gov
Undersøgelse Kontakt Backup
- Navn: Michell J Manu, R.N.
- Telefonnummer: (240) 529-3415
- E-mail: michell.manu@nih.gov
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forenede Stater, 20892
- Rekruttering
- National Institutes of Health Clinical Center
-
Kontakt:
- National Cancer Institute Referral Office
- Telefonnummer: 888-624-1937
- E-mail: ncimo_referrals@mail.nih.gov
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Primary clinical; healthy volunteers may include NIH employees
Beskrivelse
- INCLUSION CRITERIA:
Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible.
Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
Ability to understand and the willingness to sign a written informed consent document.
INCLUSION FOR APHERESIS:
Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference.
Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3)
Weight greater than 25 kg
HIV negative
Prothrombin Time - within normal limits
Partial Thromboplastin Time - within normal limits
Medically indicated central line in place or adequate peripheral venous access
EXCLUSION CRITERIA:
None.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Healthy Volunteers
Healthy volunteers 18 years of age and older |
|
Participants
Participants with cancer 18 years of age and older |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Tidsramme: ongoing
|
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis. |
ongoing
|
|
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
Tidsramme: ongoing
|
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes. |
ongoing
|
|
Collection of tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
Tidsramme: ongoing
|
Analyze tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects. |
ongoing
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jennifer L Marte, National Cancer Institute (NCI)
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Tarmsygdomme
- Luftvejssygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Kolorektale neoplasmer
- Intestinale neoplasmer
- Lungesygdomme
- Leversygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Tyktarmssygdomme
- Hudsygdomme
- Brystsygdomme
- Hud- og bindevævssygdomme
- Neoplasmer
- Prostatiske neoplasmer
- Lungeneoplasmer
- Colon neoplasmer
- Brystneoplasmer
- Neoplasmer i leveren
Andre undersøgelses-id-numre
- 020179
- 02-C-0179
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
IPD-delingstidsramme
Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
IPD-delingsadgangskriterier
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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