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FIT vs Cologuard Tests for Colorectal Cancer Screening (CARES Trial)

N/A
Waitlist Available
Led By Jennifer Haas, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial will compare two colorectal cancer screening tests to find which one is more successful and feasible in community health centers. Patients will be sent tests in the mail and asked to mail them back. Researchers will measure completion rates of each test.

Who is the study for?
This trial is for people aged 45-75 who've visited a participating community clinic in the last two years, are alive, and speak English or Spanish. It's not for those with Ulcerative Colitis, Crohn's disease, existing colorectal cancer, or recent colorectal screening tests.
What is being tested?
The study compares two at-home CRC screening methods: FIT kit and Cologuard. Sent by mail to participants overdue for CRC screening at community health centers, researchers will see which test has higher completion rates and is more suitable for these settings.
What are the potential side effects?
Since this trial involves non-invasive home-based screening tests (FIT kit and Cologuard), there are no direct side effects from the interventions themselves.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CRC Screening Completion Rates
Secondary study objectives
Diagnostic Colonoscopy Completion Rates

Trial Design

2Treatment groups
Active Control
Group I: Mailed FIT KitActive Control1 Intervention
A FIT kit mailed to the patient's home
Group II: CologuardActive Control1 Intervention
A Cologuard test mailed to the patient's home

Find a Location

Who is running the clinical trial?

University of California, Los AngelesOTHER
1,554 Previous Clinical Trials
10,258,859 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,225,466 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
34,848 Total Patients Enrolled

Media Library

Cologuard Screening Test (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05714644 — N/A
Colorectal Cancer Research Study Groups: Mailed FIT Kit, Cologuard
Colorectal Cancer Clinical Trial 2023: Cologuard Screening Test Highlights & Side Effects. Trial Name: NCT05714644 — N/A
Cologuard Screening Test (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05714644 — N/A
~2336 spots leftby Sep 2025
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