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Clinical Trial Record

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Quebec Pancreas Cancer Study

2012-03-12

2025-01

2025-01

2000

Study Overview

Quebec Pancreas Cancer Study

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.

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.

  • Pancreas Cancer
  • Pancreatic Cancer
  • Pancreas Neoplasm
  • Pancreas Cyst
  • Pancreatic Precancerous Condition
  • Familial Pancreatic Cancer
  • Hereditary Cancer
  • Bile Duct Cancer
  • Ampullary Cancer
  • Duodenal Cancer
  • Gallbladder Cancer
    • 2018-3171

    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 Registration Dates Results Reporting Dates Study Record Updates

    2019-09-24  

    N/A  

    2024-04-16  

    2019-09-25  

    N/A  

    2024-04-17  

    2019-09-26  

    N/A  

    2024-04  

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    Design Details

    Primary Purpose:
    N/A

    Allocation:
    N/A

    Interventional Model:
    N/A

    Masking:
    N/A

    Arms and Interventions

    Participant Group/ArmIntervention/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.

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Knowledge and Tissue BankCreate 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
    Secondary Outcome MeasuresMeasure DescriptionTime Frame

    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

    Name: Adeline Cuggia, MSc

    Phone Number: 514-934-1934

    Email: cancer.pancreas@mcgill.ca

    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.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:
    18 Years

    Accepts Healthy Volunteers:

      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.

    Collaborators and Investigators

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

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

      Publications

      The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

      General Publications

      • Smith AL, Bascunana C, Hall A, Salman A, Andrei AZ, Volenik A, Rothenmund H, Ferland D, Lamoussenery D, Kamath AS, Amre R, Caglar D, Gao ZH, Haegert DG, Kanber Y, Michel RP, Omeroglu-Altinel G, Asselah J, Bouganim N, Kavan P, Arena G, Barkun J, Chaudhury P, Gallinger S, Foulkes WD, Omeroglu A, Metrakos P, Zogopoulos G. Establishing a clinic-based pancreatic cancer and periampullary tumour research registry in Quebec. Curr Oncol. 2015 Apr;22(2):113-21. doi: 10.3747/co.22.2300.
      • Andrei AZ, Hall A, Smith AL, Bascunana C, Malina A, Connor A, Altinel-Omeroglu G, Huang S, Pelletier J, Huntsman D, Gallinger S, Omeroglu A, Metrakos P, Zogopoulos G. Increased in vitro and in vivo sensitivity of BRCA2-associated pancreatic cancer to the poly(ADP-ribose) polymerase-1/2 inhibitor BMN 673. Cancer Lett. 2015 Aug 1;364(1):8-16. doi: 10.1016/j.canlet.2015.04.003. Epub 2015 Apr 9.
      • Smith AL, Alirezaie N, Connor A, Chan-Seng-Yue M, Grant R, Selander I, Bascunana C, Borgida A, Hall A, Whelan T, Holter S, McPherson T, Cleary S, Petersen GM, Omeroglu A, Saloustros E, McPherson J, Stein LD, Foulkes WD, Majewski J, Gallinger S, Zogopoulos G. Candidate DNA repair susceptibility genes identified by exome sequencing in high-risk pancreatic cancer. Cancer Lett. 2016 Jan 28;370(2):302-12. doi: 10.1016/j.canlet.2015.10.030. Epub 2015 Nov 3.
      • Smith AL, Wong C, Cuggia A, Borgida A, Holter S, Hall A, Connor AA, Bascunana C, Asselah J, Bouganim N, Poulin V, Jolivet J, Vafiadis P, Le P, Martel G, Lemay F, Beaudoin A, Rafatzand K, Chaudhury P, Barkun J, Metrakos P, Marcus V, Omeroglu A, Chong G, Akbari MR, Foulkes WD, Gallinger S, Zogopoulos G. Reflex Testing for Germline BRCA1, BRCA2, PALB2, and ATM Mutations in Pancreatic Cancer: Mutation Prevalence and Clinical Outcomes From Two Canadian Research Registries. JCO Precis Oncol. 2018 Nov;2:1-16. doi: 10.1200/PO.17.00098.
      • Li Q, Wang H, Zogopoulos G, Shao Q, Dong K, Lv F, Nwilati K, Gui XY, Cuggia A, Liu JL, Gao ZH. Reg proteins promote acinar-to-ductal metaplasia and act as novel diagnostic and prognostic markers in pancreatic ductal adenocarcinoma. Oncotarget. 2016 Nov 22;7(47):77838-77853. doi: 10.18632/oncotarget.12834.
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