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Trial Title:
Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
NCT ID:
NCT06271291
Condition:
Pancreatic Carcinoma
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-interventional study
Arm group label:
Observational
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.
Criteria for eligibility:
Study pop:
Patients with pancreatic ductal adenocarcinoma (PDAC) family history, PDAC related
genetic mutations or high risk or worrisome pancreatic cysts
Sampling method:
Non-Probability Sample
Criteria:
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:
- 2+ relatives with PDAC on same side of family where 2 affected are
first degree related to each other and at least 1 affected is first
degree related to subject;
- OR 2+ affected first degree relatives (FDR), defined as blood related
parents, siblings, or children)
- Known pathogenic/likely pathogenic (P/LP) mutation in at least one of the
following:
- CDKN2A/p16, PJS (STK11), Hereditary pancreatitis with confirmed
protease serine 1 (PRSS1)
- OR 1+FDR or second degree relative (SDR) with PDAC and a known P/LP
mutation in one or more of:
- ATM, BRCA1, BRCA2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2,
EPCAM), TP53
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:
- Obstructive Jaundice in a patient with cystic lesion of the head of the
pancreas
- Enhancing mural nodule ≥ 5 mm
- Main pancreatic duct ≥ 10 mm
- Worrisome features:
- Presence of pancreatic duct stricture, defined as focal pancreatic duct
narrowing with upstream duct => 6 mm
- Cyst ≥ 3 cm
- Enhancing mural nodule < 5 mm
- Thickened/Enhancing cyst wall
- Main duct size 5-9 mm
- Pancreatitis
- Lymphadenopathy
- Increased CA 19-9
- Cyst growth rate ≥ 5 mm /2 years
Exclusion Criteria:
- * Is unable to provide informed consent
- Has received a non-autologous bone marrow transplant or has an active
hematologic malignancy (i.e., leukemia or lymphoma)
- Current or prior history of PDAC or total pancreatectomy
- Is currently a prison inmate
- Is not able to speak or read English
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Contact:
Last name:
Ajay Goel, Ph.D.
Phone:
626-256-4673
Phone ext:
85200
Investigator:
Last name:
Ajay Goel, Ph.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Shounak Majumder, M.D.
Email:
Principal Investigator
Facility:
Name:
University of Pittsburgh
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Contact:
Last name:
Randall Brand, M.D.
Phone:
412-864-7516
Start date:
November 1, 2024
Completion date:
November 1, 2029
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06271291
https://www.mayo.edu/research/clinical-trials
