Clinical trial NCT04104230: Quebec Pancreas Cancer Study
Official title: Quebec Pancreas Cancer Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Keywords: Cancer Genetics
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Knowledge and Tissue Bank
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: George Zogopoulos, MD, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.
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.