Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271291
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-02-14
Brief Title:
Pancreatic Cancer Detection Consortium PCDC Prospective Cohorts
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Pancreatic Cancer Detection Consortium PCDC Prospective Cohorts
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This study evaluates individuals without pancreatic cancer but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured
Detailed Description:
PRIMARY OBJECTIVES
I To develop a cohort biobank of biospecimens and data of subjects without pancreatic cancer who are at highrisk for pancreatic cancer due to a strong family history a mutation in a known pancreatic cancer predisposition gene or fukuoka worrisome or high-risk pancreatic cysts
II To follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes
III To make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs
OUTLINE This is an observational study
Participants undergo blood sample collection complete questionnaires have their medical records reviewed and undergo pancreatic cyst fluid collection during standard of care endoscopic ultrasounds fine needle aspiration
I To develop a cohort biobank of biospecimens and data of subjects without pancreatic cancer who are at highrisk for pancreatic cancer due to a strong family history a mutation in a known pancreatic cancer predisposition gene or fukuoka worrisome or high-risk pancreatic cysts
II To follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes
III To make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs
OUTLINE This is an observational study
Participants undergo blood sample collection complete questionnaires have their medical records reviewed and undergo pancreatic cyst fluid collection during standard of care endoscopic ultrasounds fine needle aspiration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U24CA274496 | NIH | Mayo Clinic in Rochester | httpsreporternihgovquickSearchU24CA274496 |
| NCI-2024-00504 | REGISTRY | None | None |
| 23-000161 | OTHER | None | None |
| P30CA015083 | NIH | None | None |
| U01CA210138 | NIH | None | None |