Blutentnahme bei Krebspatienten
Erwerb von Bioproben von menschlichen Probanden
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Jennifer L Marte
- Telefonnummer: (301) 496-7214
- E-Mail: martej@mail.nih.gov
Studieren Sie die Kontaktsicherung
- Name: Michell J Manu, R.N.
- Telefonnummer: (240) 529-3415
- E-Mail: michell.manu@nih.gov
Studienorte
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-
Maryland
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Bethesda, Maryland, Vereinigte Staaten, 20892
- Rekrutierung
- National Institutes of Health Clinical Center
-
Kontakt:
- National Cancer Institute Referral Office
- Telefonnummer: 888-624-1937
- E-Mail: ncimo_referrals@mail.nih.gov
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Primary clinical; healthy volunteers may include NIH employees
Beschreibung
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
Healthy Volunteers
Healthy volunteers 18 years of age and older |
|
Participants
Participants with cancer 18 years of age and older |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jennifer L Marte, National Cancer Institute (NCI)
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Geschätzt)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Genitale Neubildungen, männlich
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Genitalerkrankungen, männlich
- Prostataerkrankungen
- Männliche Urogenitalerkrankungen
- Darmerkrankungen
- Erkrankungen der Atemwege
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Kolorektale Neubildungen
- Darmtumoren
- Lungenkrankheit
- Leberkrankheiten
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Darmerkrankungen
- Hautkrankheiten
- Brusterkrankungen
- Haut- und Bindegewebserkrankungen
- Neubildungen
- Prostataneoplasmen
- Lungentumoren
- Darmneoplasmen
- Neoplasien der Brust
- Lebertumoren
Andere Studien-ID-Nummern
- 020179
- 02-C-0179
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
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-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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