Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
CellPath Therapeutics, Inc
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01474564
First received: November 15, 2011
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pancreatic Adenocarcinoma |
Other: Blood draw |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- isolating and enriching circulating tumorigenic cells [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- successful gene expression profiling [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Blood
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Other: Blood draw
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
MSKCC clinics
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474564
Contacts
| Contact: Kenneth Yu, M.D., M.Sc. | 646-888-4188 | |
| Contact: Eileen O'Reilly, MD | 646-888-4182 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Kenneth Yu, M.D., M.Sc. 646-888-4188 | |
| Contact: Eileen O'Reilly, MD 646-888-4182 | |
| Principal Investigator: Kenneth Yu, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
CellPath Therapeutics, Inc
Investigators
| Principal Investigator: | Kenneth Yu, M.D., M.Sc. | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01474564 History of Changes |
| Other Study ID Numbers: | 11-141 |
| Study First Received: | November 15, 2011 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Blood draw pancreas Tumorigenic Cells 11-141 |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous |
ClinicalTrials.gov processed this record on May 23, 2013