Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

Pancreatic Carcinoma Clinical Trial

Official title:

Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06271291
• Other study ID #: 23-000161
• Secondary ID: NCI-2024-0050423
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: May 1, 2029

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15000
• Est. completion date: May 1, 2029
• Est. primary completion date: May 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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: Subject has provided a pre-treatment biospecimen after diagnosis with pancreatic ductal adenocarcinoma (PDAC) or it has been determined that collection of a pre-treatment biospecimen sample after PDAC diagnosis is infeasible.; Enrollment cyst determined to not be mucinous and thus not worthy of ongoing surveillance.; Subject has had a complete pancreatectomy.; Subject has died.; Study funding has ended	Up to study completion, as defined in description