Exceptional Responders With Pancreatic Cancer to Chemotherapy

November 19, 2020 updated by: Adera Labs, LLC

Evaluation of Exceptional Responders With Pancreatic Cancer

This is an observational study enrolling patients with pancreatic cancer to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is an observational study of patients with pancreatic cancer to identify genomic expression differences obtained from their circulating tumor cells between exceptional responders and non-responders to standard of care chemotherapy. This study requires a 10 mL heparinized peripheral blood sample from each study participant at the time of enrollment to isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression profile will define genomic patterns using Nearest Template Prediction for a predetermined panel of therapeutic agents based on standard of care. Chemotherapy selection is physician-choice. Information regarding disease progression will be gathered. Data analysis will be performed in study participants in the setting of ongoing disease progression.

Study Type

Observational

Enrollment (Anticipated)

90

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
    • California
      • Los Angeles, California, United States, 90024
        • The Pancreatic Cancer Treatment Center of Los Angeles

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with pancreatic cancer

Description

Inclusion Criteria:

  • Histological or cytological confirmation of pancreatic adenocarcinoma.
  • Patient is treatment-naïve or currently receiving chemotherapy.
  • ECOG performance status 0-2.
  • Patients must have a hemoglobin of 7.5 g/dl or greater and be hemodynamically stable and/or physiologically compensated for their anemia.

Exclusion Criteria:

  • HIV positive on antiretroviral therapy
  • Pregnant or lactating
  • Prior organ allograft
  • Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment

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
Metastatic Pancreatic Cancer
Participants with metastatic pancreatic cancer treated with physician-choice standard of care chemotherapy.
Drug: Standard of care chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify exceptional responders with pancreatic cancer to standard of care chemotherapy
Time Frame: Six years
Identify responders and non-responders
Six years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of genomic profiles from circulating cells with overall survival
Time Frame: Six years
Genomic expression profiles correlated with progression free and overall survival
Six years

Collaborators and Investigators

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

Sponsor

Adera Labs, LLC

Collaborators

Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
The Pancreatic Cancer Treatment Center of Los Angeles

Investigators

  • Study Director: Brian McCarthy, PhD, Adera Labs

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

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

October 1, 2015

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADRL-003

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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