Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
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 9, 2014
Last verified: April 2014

November 15, 2011
April 9, 2014
November 2011
November 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01474564 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood

Non-Probability Sample

MSKCC clinics

Pancreatic Adenocarcinoma
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.
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.
Intervention: Other: Blood draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kenneth Yu, M.D., M.Sc. 646-888-4188
Contact: Eileen O'Reilly, MD 646-888-4182
United States
 
NCT01474564
11-141
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
CellPath Therapeutics, Inc
Principal Investigator: Kenneth Yu, M.D., M.Sc. Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP