Quebec Pancreas Cancer Study (QPCS)

George Zogopoulos

Status: Enrolling

Conditions: Gallbladder Cancer; Bile Duct Cancer; Pancreatic Precancerous Condition; Pancreas Cancer; Hereditary Cancer; Pancreas Neoplasm; Ampullary Cancer; Pancreas Cyst; Duodenal Cancer; Familial Pancreatic Cancer; Pancreatic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04104230

2018-3171

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

2,000 participants in 5 patient groups

Individuals Affected With Pancreatic Cancer

Description:

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

Individuals Affected with Related Cancer

Description:

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

Individuals Affected With Pancreatic Neoplasm

Description:

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

High-Risk Individuals

Description:

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

Healthy Controls

Description:

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