Clinical trial NCT06271291: Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
Official title: Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-02-21
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic ductal adenocarcinoma (PDAC) family history, PDAC related genetic mutations or high risk or worrisome pancreatic cysts

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.

Eligibility 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

Primary outcomes:
measure: Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer
timeFrame: Baseline (at enrollment)
measure: Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes
timeFrame: Up to study completion, as defined in description
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Mayo Clinic in Rochester
name: Ann L. Oberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: