Quebec Pancreas Cancer Study

NCT ID: NCT04104230

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-12

Study Completion Date

2025-01-31

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals Affected With Pancreatic Cancer

Individuals affected with pancreatic adenocarcinoma, with or without a family history of pancreatic adenocarcinoma.

No interventions assigned to this group

Individuals Affected with Related Cancer

Individuals affected with bile duct cancer, ampullary cancer, duodenal cancer or gallbladder cancer.

No interventions assigned to this group

Individuals Affected With Pancreatic Neoplasm

Individuals affected with pancreatic neoplasm, cyst or pre-cancerous lesion, with or without a family history of pancreatic adenocarcinoma.

No interventions assigned to this group

High-Risk Individuals

Individuals at high lifetime risk of pancreatic adenocarcinoma due to familial pancreatic cancer or hereditary cancer predisposition.

No interventions assigned to this group

Healthy Controls

Healthy individual at general population lifetime risk of pancreatic cancer and related cancers.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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George Zogopoulos

OTHER

Sponsor Role lead

Responsible Party

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George Zogopoulos

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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George Zogopoulos, MD, PhD

Role: STUDY_DIRECTOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

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McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Adeline Cuggia, MSc

Role: CONTACT

514-934-1934 ext. 76333

Facility Contacts

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Adeline Cuggia, MSc

Role: primary

514-934-1934 ext. 76333

References

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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.

Reference Type BACKGROUND
PMID: 25908910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25864590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26546047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35135108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27788482 (View on PubMed)

Related Links

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Other Identifiers

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2018-3171

Identifier Type: -

Identifier Source: org_study_id

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