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Cancer Screening Test

Stool DNA Test for Colorectal Cancer

N/A

Waitlist Available

Led By Diana Redwood, PhD

Research Sponsored by Alaska Native Tribal Health Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of familial adenomatous polyposis

Previous colonoscopic evidence of inflammatory bowel disease, Crohn's disease, colorectal adenomas, or CRC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new at-home colorectal cancer screening test in Alaska Native communities to see if it increases screening rates.

Who is the study for?

This trial is for Alaska Native adults who can get healthcare through the Alaska Tribal Health System, have visited it within the last three years, and are due for colorectal cancer screening. It's not open to those with certain genetic conditions or a history of bowel diseases, polyps, cancer, or colectomy.

What is being tested?

The study tests an at-home stool DNA test (Cologuard®) to see if it increases colorectal cancer screening rates in Alaska Native communities. The research includes focus groups and a three-arm randomized trial comparing different levels of intervention intensity.

What are the potential side effects?

As this is a non-invasive screening test rather than a medication or therapy, traditional side effects are not applicable. However, there may be indirect consequences related to receiving positive results such as anxiety or stress.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a family history of multiple colon polyps.

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I have had colon issues like IBD, Crohn's, polyps, or colon cancer.

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I have a family history of non-polyposis colorectal cancer.

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I have had surgery to remove part or all of my colon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Colorectal cancer screening

Secondary study objectives

Diagnostic follow-up

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Usual CareActive Control1 Intervention

usual care (i.e., opportunistic screening recommendation at a clinic visit)

Group II: High IntensityActive Control1 Intervention

navigated tribal health worker outreach, a mailed MT-sDNA kit, mailed culturally appropriate educational material describing CRC screening options available and follow-up reminders

Group III: Medium IntensityActive Control1 Intervention

navigated tribal health worker outreach, a mailed MT-sDNA kit, mailed culturally appropriate educational material describing CRC screening options available and follow-up reminders

0 / 4Eligibility criteria met