Quebec Pancreas Cancer Study

Pancreatic Cancer Clinical Trial

— QPCS  

Official title:

Quebec Pancreas Cancer Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04104230
• Other study ID #: 2018-3171
• Status: Recruiting
• Start date: March 12, 2012
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Adeline Cuggia, MSc
• Phone: 514-934-1934
• Email: cancer.pancreas[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ampullary Cancer
• Bile Duct Cancer
• Bile Duct Neoplasms
• Duodenal Cancer
• Duodenal Neoplasms
• Familial Pancreatic Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Hereditary Cancer
• Pancreas Cancer
• Pancreas Cyst
• Pancreas Neoplasm
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatic Precancerous Condition
• Precancerous Conditions

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
George Zogopoulos

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge and Tissue Bank	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