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Quebec Pancreas Cancer Study (QPCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04104230
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
George Zogopoulos, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease
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

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Quebec Pancreas Cancer Study
Actual Study Start Date : March 12, 2012
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025


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.



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood and/or saliva samples, tumor/tissue samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104230


Contacts
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Contact: Adeline Cuggia, MSc 514-934-1934 ext 76333 cancer.pancreas@mcgill.ca

Locations
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Canada, Quebec
McGill University Health Centre Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Adeline Cuggia, MSc    514-934-1934 ext 76333    cancer.pancreas@mcgill.ca   
Principal Investigator: George Zogopoulos, MD, PhD         
Sponsors and Collaborators
George Zogopoulos
Investigators
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Study Director: George Zogopoulos, MD, PhD McGill University Health Centre/Research Institute of the McGill University Health Centre

Additional Information:
Publications:
Smith AL, Wong C, Cuggia A, Borgida A, Holter S, Hall A, Connor AA, Bascuñana 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 Precision Oncology 2018 :2, 1-16.

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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: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by George Zogopoulos, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Cancer Genetics
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Duodenal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Biliary Tract Neoplasms
Gallbladder Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Precancerous Conditions
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Diseases
Bile Duct Diseases
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Pancrelipase
Gastrointestinal Agents