Clinical Trials Logo
  1. Home
  2. Pancreatic Cancer
  3. NCT04883450
  4. Details
NCT04883450 Clinical Trial

PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— PRO-TECT  

Official title:
PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04883450
Other study ID # 12135
Secondary ID R01CA230442
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date June 30, 2025

Study information
Verified date January 2024
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

The goal of this study is to establish a platform for development and implementation of a data-driven risk model for detection of early stage pancreatic cancer within an integrated health care setting. Patients at increased risk for pancreatic cancer as identified by the risk model will be invited to participate in a prospective study to assess the accuracy of this approach for detection of early stage pancreatic cancer.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 126
Est. completion date June 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years to 84 Years
Eligibility Inclusion Criteria: 1. Patient must have 6 months of membership 2. Patient has a measure for weight, Hemoglobin A1C, and Alanine transaminase (ALT) within the past 6 months 3. Patient must have an increased predicted 18-month risk of pancreatic cancer based on the PRO-TECT model 4. Speaks English or Spanish Exclusion Criteria: 1. Previous or current history of pancreatic cancer 2. Metastatic cancer 3. Current active cancer or undergoing chemotherapy for cancer 4. Currently pregnant or breastfeeding 5. Class IV heart failure 6. Cirrhosis with ascites and/or varices 7. Currently in a skilled nursing facility or under hospice care 8. Has metal parts or implanted devices in the body, such as a pacemaker, defibrillator, or shrapnel 9. End stage renal disease 10. Cognitive impairment such that the person is unable to provide informed consent

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Kaiser Permanente Southern California Pasadena California

Sponsors (2)
Lead Sponsor Collaborator
Kaiser Permanente National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT06054984 - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04927780 - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Phase 3
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Terminated NCT03140670 - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy Phase 2
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05168527 - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05391126 - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care N/A
Terminated NCT03300921 - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer Phase 1
Completed NCT03153410 - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas Early Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT05679583 - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Recruiting NCT04183478 - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer Phase 2/Phase 3
Terminated NCT03600623 - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Completed NCT04290364 - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study