PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer

NCT04883450 | Unknown

• 2 other identifiers: 12135R01CA230442
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model.

Conditions

Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (1)

• Incidence of pancreatic ductal adenocarcinoma (PDAC) in the high predicted risk group

  Enrolled subjects will be followed for 18 months to determine the incidence rate of PDAC

  18-Month

Study Arms (1)

Risk of pancreatic cancer

Subjects with an increased predicted 18-month risk of pancreatic cancer

Diagnostic Test: Magnetic resonance imaging (MRI)

Interventions

Magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

All enrolled participants will undergo magnetic resonance imaging (MRI) at their Baseline and 18-Month follow-up visit

Risk of pancreatic cancer

Eligibility Criteria

• Age: 50 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Kaiser Permanente Southern California with at least 12 months prior to recruitment

You may qualify if:

• Patient must have 6 months of membership
• Patient has a measure for weight, Hemoglobin A1C, and Alanine transaminase (ALT) within the past 6 months
• Patient must have an increased predicted 18-month risk of pancreatic cancer based on the PRO-TECT model
• Speaks English or Spanish

You may not qualify if:

• Previous or current history of pancreatic cancer
• Metastatic cancer
• Current active cancer or undergoing chemotherapy for cancer
• Currently pregnant or breastfeeding
• Class IV heart failure
• Cirrhosis with ascites and/or varices
• Currently in a skilled nursing facility or under hospice care
• Has metal parts or implanted devices in the body, such as a pacemaker, defibrillator, or shrapnel
• End stage renal disease
• Cognitive impairment such that the person is unable to provide informed consent

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma, serum and Buffy coat) and Urine samples

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bechien U Wu, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)