Cohort Study of Pancreatic Cancer Risk
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|ClinicalTrials.gov Identifier: NCT04247503|
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : December 30, 2021
|Condition or disease|
|Familial Pancreatic Cancer|
The high mortality rate of pancreatic cancer is primarily due to the advanced stage at diagnosis in the majority of cases. The five-year survival rate for this cancer is only 9%, the poorest survival rate of any major cancer, making pancreatic cancer the third leading cancer killer that affects both men and women in the United States. Five-year survival can be improved if the cancer is detected earlier. It is thus important to apply cancer genetics, risk assessment, and early detection that can identify a population of high-risk individuals who can benefit from early detection.
A key strategy for effective early detection research in pancreatic cancer is to identify and build longitudinal high-risk cohorts and maintain data from baseline to follow up, and biobanking of repeated (annual) non-invasive biospecimen collections. The research to be performed would compare samples of participants who develop cancer over time compared to those who do not. Tests that would be applied to the biospecimen collections would use subsets of participants in designs that would provide the maximum amount of information about the performance of the assays in predicting who has cancer at an early stage [3,4].
The collection of biosamples and data for the family-based biobank resource/registry proposed here is partially funded by NCI funded U01 grants, through the PCDC . At Mayo Clinic, NCI grant U01 CA210138 is the funding source. The PCDC is committed to developing a longitudinal cohort (registry) of individuals and family members currently without pancreatic cancer, but who are at high risk due to family history of pancreatic cancer or predisposition gene mutation status. High-risk individuals will be recruited at each site, and biospecimens will be logged, stored, administered, and studied by consensus protocols of members of the PCDC. The maintenance of protocols will be maintained by the PCDC Administrative Core at Mayo Clinic. The PCDC cohort will require a long-term investment and will be most successful with multiple contributing sites.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Cohort Study of Pancreatic Cancer Risk|
|Actual Study Start Date :||December 11, 2019|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2026|
- Incidence of cancer in the risk cohort [ Time Frame: Through study completion, an average of 5 years. ]Enumeration of number of new cases of pancreatic cancer and other cancers that incidentally develop from baseline enrollment among those who enroll in the cohort. This number will be a numerator for a risk ratio. The denominator will be person years at risk starting from age 50.
- Association of baseline patient characteristics with incident cancers [ Time Frame: through study completion an average of 5 years. ]Participants will complete questionnaires seeking demographic, clinical and family history, and exposures at baseline. We will evaluate by association studies (comparing participants with incident cancer to those who do not develop cancer) in order to discover various characteristics that may be associated with development of cancer. Specific characteristics that will be assessed (comparing participants who develop cancer to those who do not) include age at diagnosis of prevalent cancers, sex, personal history of diabetes, and family history (first and second degree) of pancreatic cancer and other cancers.
- Measurement of test accuracy of biomarkers to detect pancreatic cancer [ Time Frame: Through study completion, an average of 5 years. ]Biospecimens collected from patients will be used to assess the performance of potential biomarkers in detecting early pancreatic cancer. Two biomarkers that will be evaluated include serum CA19-9, fasting blood glucose and/or hemoglobin A1C. Additional biomarkers will be proposed and approved by scientific review in the future. We will compare samples collected longitudinally (prior to cancer diagnosis) from participants who develop cancer, to participants who do not develop cancer, and estimate test sensitivity and performance.
Biospecimen Retention: Samples Without DNA
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): NCT04247503
|Contact: Bridget H Rathbun, CCRP||800-914-7962 ext firstname.lastname@example.org|
|Contact: Jennifer Brooksemail@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|Contact: Bridget H Rathbun, CCRP 800-914-7962 ext 1 firstname.lastname@example.org|
|Contact: Jennifer Brooks 800-914-7962 email@example.com|
|Principal Investigator: Gloria M Petersen, Ph.D.|
|Principal Investigator:||Gloria Petersen, PhD||The Mayo Clinic|