Predicting Effective Therapy in Pancreatic Cancer

April 23, 2024 updated by: Memorial Sloan Kettering Cancer Center

Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response

The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Cancer Center Basking Ridge
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center @ Suffolk
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with advanced pancreatic adenocarcinoma.

Description

Inclusion Criteria:

  • Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC, AJCC stage IV disease at time of enrollment.
  • Patient planning to receive treatment with FOLFIRINOX or gem/nab-P chemotherapy, with or without investigational agents.
  • Prior surgery, chemotherapy and/or radiation therapy for AJCC Stage I-III pancreatic adenocarcinoma is permitted.
  • ECOG performance status 0-2.
  • A minimum age of 18 years old.

Exclusion Criteria:

  • Prior chemotherapy for AJCC stage IV pancreatic adenocarcinoma
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Stage IV Pancreatic Cancer
Diagnostic test: CTC isolocation and analysis
Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 36 months
in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2017

Primary Completion (Estimated)

January 24, 2025

Study Completion (Estimated)

January 24, 2025

Study Registration Dates

First Submitted

January 25, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimated)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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