Ignite Creation Date:
2024-05-05 @ 10:26 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01102569
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2010-04-12
Brief Title:
Pancreatic Cancer Genetics
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Molecular Genetics and Epidemiology of Pancreatic Cancer in Ashkenazi Jewish Patients
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to determine the frequency of the three most common BReast CAncer gene 1 BRCA1 and BReast CAncer gene 2 BRCA2 genetic mutations that are commonly found in Ashkenazi Jewish patients with pancreatic cancer Testing for BRCA1 and BRCA2 mutations in relatives of hereditary pancreatic cancer patients may have a significant impact allowing for early screening treatment and resection of pre-malignant tissue or malignant lesions
Detailed Description:
Pancreatic cancer is the fourth leading cause of death from malignancy in the United States Up to 15 of pancreatic cancers have a hereditary component Several gene mutations and cancer syndromes have been identified that are frequently found in greater frequency in individuals with pancreatic cancer including the breast ovary cancer syndrome BRCA1BRCA2 mutations No studies adequately describe the epidemiology of inherited pancreatic cancer and genetic risk factors that may modify the penetrance of BRCA1BRCA2 mutations The primary aim of this study is to determine the frequency of BRCA1 185delAG5382insC and BRCA2 6174delT mutations in Ashkenazi Jewish pancreatic cancer patients Secondary endpoints will include determining the individual frequency of these mutations and other disease-modifying mutations death from any cause disease-free survival and stage of disease at time of presentation differences in tissue pathology risk factors treatment decisions and development of metachronous malignancies
The investigator plans to study about 100 patients which will enable the true frequency of the mutation to be estimated Although the impact of BRCA1BRCA2 mutations will be initially studied in the Ashkenazi population these data will be widely applicable to other pancreatic cancer patients carrying BRCA1BRCA2 mutations Testing for BRCA1 and BRCA2 mutations in relatives of hereditary pancreatic cancer patients may allow early screening treatment and resection of pre-malignant tissue or malignant lesions
The investigator plans to study about 100 patients which will enable the true frequency of the mutation to be estimated Although the impact of BRCA1BRCA2 mutations will be initially studied in the Ashkenazi population these data will be widely applicable to other pancreatic cancer patients carrying BRCA1BRCA2 mutations Testing for BRCA1 and BRCA2 mutations in relatives of hereditary pancreatic cancer patients may allow early screening treatment and resection of pre-malignant tissue or malignant lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None