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Head to Head Trial of Mailed Cologuard to Mailed FIT

NCT06931860 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-09-09

No results posted yet for this study

Summary

The objective of this study is to measure the comparative effectiveness of mailed outreach of two stool based tests, multi-target stool DNA (Cologuard) and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.

Conditions

  • Colorectal Cancer Screening
  • Fecal Immunochemical Test
  • Multi-target Stool DNA
  • Colorectal Cancer (CRC)

Interventions

DIAGNOSTIC_TEST

Cologuard

Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.

DIAGNOSTIC_TEST

Fecal Immunochemical Test

Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.

Sponsors & Collaborators

Principal Investigators

  • Joshua Demb, PhD, MPH · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06931860 on ClinicalTrials.gov