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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA210138 | U.S. NIH Grant/Contract | View source | |
| U24CA274496 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
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| Measure | Description | Time Frame |
|---|---|---|
| Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer | Assessed by the number of specimens collected for subjects at right risk 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. | Baseline (at enrollment) |
| Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes | Participants will be followed until study completion, defined as when one or more of the following occur:
| Up to study completion, as defined in description |
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Inclusion Criteria:
PDAC FAMILY HISTORY OR PDAC RELATED GENETIC MUTATIONS:
Age: 50 or older, plus at least one of the following:
Mutation unknown or absent:
Known pathogenic/likely pathogenic (P/LP) mutation in at least one of the following:
OR 1+ or second degree relative (SDR) with PDAC and a known P/LP mutation in one or more of:
HIGH-RISK OR WORRISOME PANCREATIC CYSTS:
18 years of age or greater and meeting Fukuoka worrisome (FW) or Fukuoka high-risk (FHR) criteria
High risk stigmata:
Worrisome features:
Exclusion Criteria:
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Patients with pancreatic ductal adenocarcinoma (PDAC) family history, PDAC related genetic mutations or high risk or worrisome pancreatic cysts
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ann L. Oberg, PhD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Withdrawn | Scottsdale | Arizona | 85258 | United States | |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Biospecimens of subjects without pancreatic cancer who are at high-risk 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. Biospecimens will remain available for research beyond the end of study funding.
| Piedmont Healthcare |
| Recruiting |
| Atlanta |
| Georgia |
| 30309 |
| United States |
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| OSF Saint Francis Medical Center | Recruiting | Peoria | Illinois | 61615 | United States |
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| The Johns Hopkins University School of Medicine | Recruiting | Baltimore | Maryland | 21231 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198-6805 | United States |
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| Oregon Health & Science University | Recruiting | Portland | Oregon | 97201 | United States |
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| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |