Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma
1 other identifier
observational
83
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2011
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 15, 2011
CompletedFirst Posted
Study publicly available on registry
November 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedOctober 2, 2019
October 1, 2019
7.9 years
November 15, 2011
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
isolating and enriching circulating tumorigenic cells
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.
1 year
Secondary Outcomes (1)
successful gene expression profiling
1 year
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
MSKCC clinics
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Adera Labs, LLCcollaborator
Study Sites (5)
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York, 10591, United States
Related Links
Biospecimen
Blood
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Yu, M.D., M.Sc.
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2011
First Posted
November 18, 2011
Study Start
November 1, 2011
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
October 2, 2019
Record last verified: 2019-10