- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01474564
Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma
The purpose of this study is to collect blood samples and study cancer cells found in these blood samples from patients with pancreatic cancer. Prior research has discovered that tumor cells can be collected from the blood of patients with pancreatic and other cancers.
The physicians have developed techniques for isolating and analyzing cancer cells using a simple blood test. They will study how these cells relate to how chemotherapy works. They hope to use this information to guide choices of treatment for patients in the future.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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New York
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Commack, New York, Forenede Stater, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk
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Harrison, New York, Forenede Stater, 10604
- Memorial Sloan Kettering West Harrison
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, Forenede Stater
- Memorial Sloan Kettering at Mercy Medical Center
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Sleepy Hollow, New York, Forenede Stater, 10591
- Memoral Sloan Kettering Cancer Center at Phelps
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC.
- Patient eligible for chemotherapy treatment.
- Prior surgery, chemotherapy and/or radiation therapy for pancreatic adenocarcinoma is permitted.
- ECOG performance status 0-2.
- A minimum age of 18 years old.
Exclusion Criteria:
- Known to be HIV positive on antiretroviral therapy
- Prior organ allograft
- Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Pts with Pancreatic Adenocarcinoma
This is an observational study to assess the feasibility of 1) isolating and enriching circulating tumorigenic cells from the peripheral blood of eligible pancreatic cancer patients and 2) successful gene expression profiling of these circulating tumorigenic cells.
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Patients with pancreatic adenocarcinoma will be enrolled.
Venous blood is collected in a standard 10 ml heparin blood collection tube.
We may ask for blood samples at different times during the course of the study, specifically, before you start treatment and when your treatment changes.
During the one year of the study, the physician anticipates blood samples will be collected a minimum of one and a maximum of four times.
The amount of blood collected at any of these times will be 10 mL, about 1 tablespoon.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
isolating and enriching circulating tumorigenic cells
Tidsramme: 1 year
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A 10 mL blood sample will be drawn from participants prior to starting chemotherapy treatment.
circulating tumorigenic cells from the peripheral blood of eligible pancreatic cancer patients.
During the 1 year following enrollment, in the setting of disease progression, a subsequent 10 mL blood sample may be drawn from participants prior to changing chemotherapy treatment.
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1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
successful gene expression profiling
Tidsramme: 1 year
|
of these circulating tumorigenic cells.
For each blood sample collected, CTCs will be isolated, expanded, RNA extracted, gene expresion analysis performed and treatment profile sensitivity performed.
|
1 year
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kenneth Yu, M.D., M.Sc., Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
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
Andre undersøgelses-id-numre
- 11-141
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