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Carcinoma, Pancreatic DuctalCOMPASSNCT02750657

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

An observational study of Carcinoma, Pancreatic Ductal, run by University Health Network, Toronto at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Pancreatic Ductal
What is being tested?
Molecular Profiling
How many people
332 participants
Where
4 sitesCanada
Study dates
Dec 2015to Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Locally advanced or metastatic pancreatic ductal adenocarcinoma

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L2V7

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 3E4

  • McGill University Health Centre

    Montreal, Quebec, H4A3J1

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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.

Being tested
Molecular Profiling
Medical subject headings
Carcinoma, Pancreatic Ductal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Molecular ProfilingGenetic

    Whole Genome Sequencing

Study groups in NCT02750657
Study groupRoleWhat they receive
Patients with advanced pancreatic ductal adenocarcinomaNot described
Receives: Genetic: Molecular Profiling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

Secondary outcomes (17)

  1. Disease control rate achieved by m-FOLFIRINOX

    Measured: 5 years

  2. Disease control rate achieved by nab-paclitaxel

    Measured: 5 years

  3. 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

    Measured: 5 years

  4. 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.

    Measured: 5 years

  5. 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.

    Measured: 5 years

  6. 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.

    Measured: 5 years

  7. Overall survival defined as the interval between the date of registration and the date of death of patients treated with m-FOLFIRINOX

    Measured: 5 years

  8. Overall survival defined as the interval between the date of registration and the date of death of patients treated with nab-paclitaxel.

    Measured: 5 years

  9. Correlation between tumor genomic characteristics and m-FOLFIRINOX response using next generation sequencing.

    Measured: 5 years

  10. Correlation between tumor genomic characteristics and nab-paclitaxel response using the next generation sequencing.

    Measured: 5 years

  11. 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.

    Measured: 5 years

  12. Percentage of patients with somatic DSBR deficiency who might benefit from a personalized treatment strategy such as combination of cisplatin and a PARP inhibitor.

    Measured: 5 years

  13. 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).

    Measured: 5 years

  14. Percentage of patients with rare but targetable somatic mutations.

    Measured: 5 years

  15. Difference in disease control rate between patients with tumor smoking signature and those without.

    Measured: 5 years

  16. Difference in overall survival between patients with tumor smoking signature and those without.

    Measured: 5 years

  17. Correlation with tumor molecular characteristics and toxicities to treatment using next generation sequencing.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionAug 2025
  4. Study completionAug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02750657
Sponsor's protocol ID
COMPASS-001
Acronym
COMPASS
Status last verified
Nov 2025
First submitted
19 Jan 2016
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • Karasinska JM, Topham JT, Kalloger SE, Jang GH, Denroche RE, Culibrk L, Williamson LM, Wong HL, Lee MKC, O'Kane GM, Moore RA, Mungall AJ, Moore MJ, Warren C, Metcalfe A, Notta F, Knox JJ, Gallinger S, Laskin J, Marra MA, Jones SJM, Renouf DJ, Schaeffer DF. Altered Gene Expression along the Glycolysis-Cholesterol Synthesis Axis Is Associated with Outcome in Pancreatic Cancer. Clin Cancer Res. 2020 Jan 1;26(1):135-146. doi: 10.1158/1078-0432.CCR-19-1543. Epub 2019 Sep 3.

    PubMed 31481506

  • Aung KL, Fischer SE, Denroche RE, Jang GH, Dodd A, Creighton S, Southwood B, Liang SB, Chadwick D, Zhang A, O'Kane GM, Albaba H, Moura S, Grant RC, Miller JK, Mbabaali F, Pasternack D, Lungu IM, Bartlett JMS, Ghai S, Lemire M, Holter S, Connor AA, Moffitt RA, Yeh JJ, Timms L, Krzyzanowski PM, Dhani N, Hedley D, Notta F, Wilson JM, Moore MJ, Gallinger S, Knox JJ. Genomics-Driven Precision Medicine for Advanced Pancreatic Cancer: Early Results from the COMPASS Trial. Clin Cancer Res. 2018 Mar 15;24(6):1344-1354. doi: 10.1158/1078-0432.CCR-17-2994. Epub 2017 Dec 29.

    PubMed 29288237

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Pancreatic Ductal, run by University Health Network, Toronto at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02750657, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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