QPCS: Quebec Pancreas Cancer Study

Sponsor
George Zogopoulos (Other)
Overall Status
Recruiting
CT.gov ID
NCT04104230
Collaborator
(none)
2,000
1
153.7
13

Study Details

Study Description

Brief Summary

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.

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2000 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Quebec Pancreas Cancer Study
Actual Study Start Date :
Mar 12, 2012
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Knowledge and Tissue Bank [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 McGill University Health Centre Montréal Quebec Canada H4A 3J1

Sponsors and Collaborators

  • George Zogopoulos

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
George Zogopoulos, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier:
NCT04104230
Other Study ID Numbers:
  • 2018-3171
First Posted:
Sep 26, 2019
Last Update Posted:
Feb 23, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by George Zogopoulos, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2021