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

NCT ID: NCT01474564

Last Updated: 2019-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood draw

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adera Labs, LLC

INDUSTRY

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Yu, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, United States

Site Status

Memorial Sloan Kettering West Harrison

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Site Status

Memoral Sloan Kettering Cancer Center at Phelps

Sleepy Hollow, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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11-141

Identifier Type: -

Identifier Source: org_study_id

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