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

Completed

• Conditions: Pancreatic Adenocarcinoma
• Interventions: Other: Blood draw

• Registration Number: NCT01474564
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-18
• Status Verified: 2019-10
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pts with Pancreatic Adenocarcinoma	Blood draw	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.

Primary Outcome Measures

Name	Time	Method
isolating and enriching circulating tumorigenic cells	1 year	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

Name	Time	Method
successful gene expression profiling	1 year	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.

Trial Locations

Locations (5)

Memorial Sloan Kettering West Harrison; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, 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, United States