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Germline Mutations in Pancreatic Adenocarcinoma (PaMPA)

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ClinicalTrials.gov Identifier: NCT03982446
Recruitment Status : Active, not recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hellenic Cooperative Oncology Group

Brief Summary:

This study will assess the hereditary component of pancreatic cancer in the largest series of patients up to date through the parallel analysis of 62 cancer-associated genes. The investigators will obtain germline DNA from blood samples that have been collected from 2000 to 2019 from patients with pancreatic cancer. The investigators plan to analyze germline DNA for mutations and single nucleotide polymorphisms (SNPs) in genes that have been previously linked to a predisposition towards cancer.

The outcome can provide useful insight on the overall understanding of pancreatic pathogenesis while possible associations with age of diagnosis, tumor stage and other cancer types might arise. In addition to that, it can lead to the characterization of new variants or even new genes that predispose to pancreatic cancer.

Confirmed deleterious mutations in established cancer genes can provide valuable clinical information that can lead to effective, individualized patient management. Furthermore, family relatives of the individuals found to carry mutations can also benefit from established screening protocols for various cancer types, such as frequent colonoscopies in the case of an MMR mutation predisposing for Lynch syndrome, or preventative surgeries in the case of a deleterious BRCA1 or BRCA2 mutation. In addition to that, specific therapies that have been previously shown to be effective in breast or ovarian cancer patients with BRCA1 & BRCA2 mutations, such as platinum-based chemotherapy and PARP inhibitors can be also effective in mutations carriers with pancreatic cancer.


Condition or disease Intervention/treatment
Germline Mutation Abnormality Pancreatic Cancer Predisposition, Genetic Hereditary Cancer Genetic: Mutations

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence of Germline Pathogenic Mutations in Patients With Pancreatic Adenocarcinoma
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with germline mutations
This group will comprise of patients with pancreatic cancer who carry pathogenic mutations in genes associated with a predisposition to cancer.
Genetic: Mutations
Patients without germline mutations
This group will comprise of patients with pancreatic cancer who did not carry pathogenic mutations in any of the genes tested, that have been previously shown to be associated with a predisposition to cancer.
Genetic: Mutations



Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Time Frame: through the completion of the study, up to 2 years ]
    Evaluation of overall survival in patients with pancreatic cancer, from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first


Biospecimen Retention:   Samples With DNA
Germline DNA from white blood cells will be isolated using a commercially available blood DNA extraction kit. Remaining germline DNA will be safely stored in HeCOG's repository.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Genomic DNA from patients with pancreatic cancer will be retrospectively and prospectively collected from the Hellenic Cooperative Oncology Group (HeCOG) Tumor Repository, through years 2000-2019. Written informed consent has already been obtained from all patients for the use and storage of their biologic material along with their approval for their participation in research studies. The study will be in agreement with the 1975 Helsinki statement, revised in 1983.
Criteria

Inclusion Criteria:

  • Patients diagnosed with adenocarcinoma of the pancreas
  • All disease stages

Exclusion criteria

  • Patients with pancreatic cancer, other than adenocarcinoma
  • Non-eligible blood samples

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): NCT03982446


Locations
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Greece
Hellenic Oncology Cooperative Group
Athens, Greece
Sponsors and Collaborators
Hellenic Cooperative Oncology Group

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Responsible Party: Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT03982446     History of Changes
Other Study ID Numbers: Germline_pancreas
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Disease Susceptibility
Genetic Predisposition to Disease
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes