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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 10, 2014
Last verified: October 2014
  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 2015
Estimated Primary Completion Date: November 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Kenneth Yu, MD    646-888-4188      
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         
Memorial Sloan-Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Kennneth Yu, MD    646-888-4188      
Memoral Sloan Kettering Cancer Center at Phelps Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Kenneth Yu, MD    646-888-4188      
Memoral Sloan Kettering Cancer Center@Phelps Recruiting
Sleepy Hollow, New York, United States
Contact: Kenneth Yu, MD    646-888-4188      
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: October 10, 2014
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
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2014