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

November 14, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Montreal, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with advanced pancreatic ductal adenocarcinoma
Genetic: Molecular Profiling
Whole Genome Sequencing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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