At-home test kits mailed to thousands could catch colon cancer early
NCT ID NCT04406714
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether mailing free stool tests (FIT kits) to people's homes could increase colorectal cancer screening rates. Over 4,300 adults aged 45-75 who were at average risk took part. The goal was to make screening easier for those who might otherwise skip it, especially in underserved communities.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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4,318 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 45-75 years * At average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative \[father, mother, sister, brother\], or diagnosis of inflammatory bowel disease) * No record of fecal occult blood test (FOBT)/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date * No record of any CRC diagnosis or total colectomy * No record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma) * Has a complete North Carolina mailing address in the EHR * Active patient of the clinic (seen within the past 18 months) at the time of randomization * No record of a positive (abnormal) FIT result in the first study round (Trial Ages 50-75 only) Exclusion Criteria: * Age younger than 45 years or older than 75 years * Not at average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative \[father, mother, sister, brother\], or diagnosis of inflammatory bowel disease) * Record of FOBT/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or CT colonography within 10 years of the EHR query date * Record of any CRC diagnosis or total colectomy * Record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma) * Does not have a complete North Carolina mailing address in the EHR * Not an active patient of the clinic (not seen within the past 18 months) at the time of randomization * Record of a positive (abnormal) FIT result reported during the first study round (Trial Ages 50-75)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Blue Ridge Health
Hendersonville, North Carolina, 28792, United States
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Roanoke Chowan Community Health Center
Ahoskie, North Carolina, 27910, United States
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Other studies related to the condition(s) this trial covers.
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