Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| University of Pittsburgh Medical Center | OTHER |
| HonorHealth Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.
The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-gene Next Generation Sequencing Panel | Genetic | Participants will have genetic testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Germline Mutation Prevalence | The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively to the clinical site within 12 weeks of a histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Associate age at diagnosis with germline mutation status and family history | 18 months | |
| Access the psychological impact of testing for hereditary pancreatic cancer | A previously validated questionnaire, the Multidimensional Impact of Cancer Risk Assessment (MICRA) will be used as a measure of the psychological impact of genetic testing. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study population will be patients who are diagnosed within 12 weeks of enrollment with Pancreatic Ductal Adenocarcinoma.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Randall Brand, MD | University of Pittsburgh | Principal Investigator |
| Nadine Tung, MD | Beth Israel Deaconess | Principal Investigator |
| Erkut Borazanci, MD | HonorHealth Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12433008 | Background | Cella D, Hughes C, Peterman A, Chang CH, Peshkin BN, Schwartz MD, Wenzel L, Lemke A, Marcus AC, Lerman C. A brief assessment of concerns associated with genetic testing for cancer: the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. Health Psychol. 2002 Nov;21(6):564-72. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood, saliva or DNA
| 18 months |
| Boston |
| Massachusetts |
| 02215-5400 |
| United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |