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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

CARES Trial 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.Check my eligibility

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.See study design

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.

CARES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

CRC Screening Completion Rates

Diagnostic Colonoscopy Completion Rates

CARES 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, Los AngelesOTHER

1,533 Previous Clinical Trials

10,260,082 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,936 Previous Clinical Trials

13,193,223 Total Patients Enrolled

Stand Up To CancerOTHER

51 Previous Clinical Trials

34,794 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to participate in this research endeavor?

"Aiming to include 8000 individuals, this clinical study is targeting those aged 45-75 suffering from colorectal cancer. To qualify for the trial, patients must have visited a participating clinic within two years of enrollment, still be alive and speak English or Spanish as their native language."

Answered by AI

Does this research have any age restrictions, particularly for individuals over 70?

"This trial's minimum age requirement is 45 and the maximum is 75, as per its inclusion criteria."

Answered by AI

Is this trial open to new enrollees at the present time?

"According to the clinicaltrials.gov page, this trial is not accepting patients at present. This research project was initially reported on May 31st 2023 and last modified June 5th 2023. Despite this particular study's current inactivity, there are 1,115 other studies recruiting participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

Jennifer S Haas, MD 2023. "Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05714644.