Quebec Pancreas Cancer Study (QPCS)

April 16, 2024 updated by: George Zogopoulos
The Quebec Pancreas Cancer Study is a prospective clinic-based study consisting of clinical, family history and epidemiologic data, with accompanying biospecimens, from patients diagnosed with either pancreas cancer, a related cancer or a related pre-cancerous condition, and their families.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The objectives of the QPCS are as follows:

  1. To study the epidemiology of pancreas cancer, related cancers and related pre-cancerous conditions, including the risk factors and patient outcomes.
  2. To characterize the contribution of known hereditary cancer syndromes to pancreas cancer, related cancers, and related pre-cancerous conditions.
  3. To identify new genetic and epigenetic changes associated with hereditary pancreas cancer, related cancers, and related pre-cancerous conditions. DNA contains the instructions used in the development and functioning of living organisms, including humans. Epigenetic changes are changes other than changes in the underlying DNA sequence.
  4. To study the tumour biology of pancreas cancer and related pre-cancerous conditions. This may include studying the tumour and the environment surrounding the tumour, as well as blood and/or saliva samples. The studies may include characterization of genetic, genomic, transcriptomic, epigenetic, proteomic, and metabolomic changes.
  5. To identify and characterize biomarkers associated with pancreas cancer, related cancers and related pre-cancerous conditions.
  6. To determine if there are any epidemiological, clinical and outcome (for example, overall survival) associations with the genetic, genomic, epigenetic, transcriptomic, proteomic, metabolomic or other biologic changes that occur in pancreas cancer, related cancers and related pre-cancerous conditions.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

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

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • George Zogopoulos, MD, PhD

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Individuals diagnosed with pancreatic cancer or related cancer followed in a hospital in Quebec.

High-risk individuals with Familial Pancreatic Cancer or hereditary predisposition to pancreatic cancer with or without a family history of pancreatic cancer.

Healthy controls.

Description

Inclusion Criteria:

  • Individual diagnosed with pancreatic cancer.
  • Individual diagnosed with a related cancer (bile duct cancer, ampullary cancer, duodenal cancer, gallbladder cancer).
  • Individual diagnosed with pancreatic neoplasm or pancreatic cyst.
  • High-risk individuals with Familial Pancreatic Cancer (3 or more relatives affected with adenocarcinoma).
  • High-risk individuals with 2 first-degree relatives affected with young-onset pancreatic adenocarcinoma (≤ 50 years old).
  • High-risk individuals with one of the following Hereditary Cancer Syndromes: Peutz-Jeghers Syndrome (STK11 gene mutation), Familial Atypical Multiple Mole Melanoma Syndrome (CDKN2A gene mutation), or Hereditary Pancreatitis (PRSS1 gene mutation) with clinical manifestations.
  • High-risk individuals with one of the following Hereditary Cancer Syndromes: Hereditary Breast and Ovarian Cancer Syndrome (BRCA1, BRCA2 or PALB2 gene mutation), Lynch Syndrome (MLH1, MSH2, MSH6, PMS2 or EPCAM gene mutation), or Hereditary Breast Cancer (ATM gene mutation), WITH a family history of cancer.

Exclusion Criteria:

  • High-risk individuals with one of the following Hereditary Cancer Syndromes: Hereditary Breast and Ovarian Cancer Syndrome (BRCA1, BRCA2 or PALB2 gene mutation), Lynch Syndrome (MLH1, MSH2, MSH6, PMS2 or EPCAM gene mutation), or Hereditary Breast Cancer (ATM gene mutation), WITHOUT a family history of cancer.

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: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Individuals Affected With Pancreatic Cancer
Individuals affected with pancreatic adenocarcinoma, with or without a family history of pancreatic adenocarcinoma.
Individuals Affected with Related Cancer
Individuals affected with bile duct cancer, ampullary cancer, duodenal cancer or gallbladder cancer.
Individuals Affected With Pancreatic Neoplasm
Individuals affected with pancreatic neoplasm, cyst or pre-cancerous lesion, with or without a family history of pancreatic adenocarcinoma.
High-Risk Individuals
Individuals at high lifetime risk of pancreatic adenocarcinoma due to familial pancreatic cancer or hereditary cancer predisposition.
Healthy Controls
Healthy individual at general population lifetime risk of pancreatic cancer and related cancers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge and Tissue Bank
Time Frame: 10 years
Create a knowledge and tissue bank for pancreatic cancer, related pre-cancerous lesions, and related cancers, including patient demographics, type of chemotherapy treatments, type of surgical procedures, other procedures, overall survival, progression-free survival, epidemiological risk factors, genetic factors and characteristics of tumour tissue.
10 years

Collaborators and Investigators

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

Sponsor

George Zogopoulos

Investigators

  • Study Director: George Zogopoulos, MD, PhD, McGill University Health Centre/Research Institute of the McGill University Health 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)

March 12, 2012

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-3171

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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