Study of Changes and Characteristics of Genes in Patients With Pancreatic Cancer for Better Treatment Selection (COMPASS)

March 8, 2024 updated by: University Health Network, Toronto

Comprehensive Molecular Characterization of Advanced Pancreatic Ductal Adenocarcinomas (PDAC) for Better Treatment Selection: A Prospective Study

Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

332

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

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L2V7
        • Kingston Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Montréal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Montréal, Quebec, Canada, H4A3J1
        • McGill University Health Centre

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

Locally advanced or metastatic pancreatic ductal adenocarcinoma

Description

Inclusion Criteria:

  • Patients must have a histological or radiological diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with borderline resectable disease are not eligible.
  • Patient must have a tumor lesion that is amenable to a core needle biopsy.
  • Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
  • Patients must be fit enough to safely undergo a tumor biopsy.
  • Age 18 years or older.
  • Eastern Cooperative Group (ECOG) performance status of 1 or less.
  • Life expectancy of greater than 90 days.
  • Patients must have normal organ and marrow function
  • Patients must undergo systemic treatment with m-FOLFIRINOX or nab-paclitaxel as a first line standard systemic palliative treatment or combination treatment with m-FOLFIRINOX or nab-paclitaxel with or without other investigational agents within a clinical trial as a first line palliative treatment.
  • Ability to understand and willing to sign a written informed consent document.

Exclusion Criteria:

  • Patients with one or more contraindications to tumor biopsy.
  • Patients who have prior systemic treatment (chemotherapy or any other anti-cancer agent) in advanced setting.
  • Patients who are currently on anti-cancer treatment including chemotherapy.
  • Patients with known brain metastases.
  • Patients with advanced PDAC who are going to be treated with gemcitabine monotherapy in advanced setting.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study 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
Patients with advanced pancreatic ductal adenocarcinoma
Genetic: Molecular Profiling
Whole Genome Sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The feasibility of prospectively identifying subgroups of patients with advanced PDAC who have distinct genomic characteristics for better treatment selection while undergoing 1st-line chemotherapy using next generation sequencing.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease control rate achieved by m-FOLFIRINOX
Time Frame: 5 years
5 years
Disease control rate achieved by nab-paclitaxel
Time Frame: 5 years
5 years
Duration of response defined as the interval between the first date of complete response or partial response and the earliest date of disease progression or death due to any cause to m-FOLFIRINOX
Time Frame: 5 years
5 years
Duration of response defined as the interval between the first date of complete response or partial response and the earliest date of disease progression or death due to any cause to nab-paclitaxel.
Time Frame: 5 years
5 years
Progression free survival defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with m-FOLFIRINOX.
Time Frame: 5 years
5 years
Progression free survival defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with nab-paclitaxel.
Time Frame: 5 years
5 years
Overall survival defined as the interval between the date of registration and the date of death of patients treated with m-FOLFIRINOX
Time Frame: 5 years
5 years
Overall survival defined as the interval between the date of registration and the date of death of patients treated with nab-paclitaxel.
Time Frame: 5 years
5 years
Correlation between tumor genomic characteristics and m-FOLFIRINOX response using next generation sequencing.
Time Frame: 5 years
5 years
Correlation between tumor genomic characteristics and nab-paclitaxel response using the next generation sequencing.
Time Frame: 5 years
5 years
Percentage of patients with germline BRCA, PALB2 and ATM mutations who might benefit from a personalized treatment strategy such as combination of cisplatin and a PARP inhibition.
Time Frame: 5 years
5 years
Percentage of patients with somatic DSBR deficiency who might benefit from a personalized treatment strategy such as combination of cisplatin and a PARP inhibitor.
Time Frame: 5 years
5 years
Percentage of patients who might benefit from immunotherapy (patients with smoking genomic signatures, patients with a hypermutated phenotype, patients with mismatch repair deficiency and patients with tumor neo-antigen expression).
Time Frame: 5 years
5 years
Percentage of patients with rare but targetable somatic mutations.
Time Frame: 5 years
5 years
Difference in disease control rate between patients with tumor smoking signature and those without.
Time Frame: 5 years
5 years
Difference in overall survival between patients with tumor smoking signature and those without.
Time Frame: 5 years
5 years
Correlation with tumor molecular characteristics and toxicities to treatment using next generation sequencing.
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Jennifer J. Knox, M.D., Princess Margaret Cancer Centre

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 (Actual)

December 1, 2015

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimated)

April 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMPASS-001

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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