Trial results for a study investigating Colorectal Cancer screening among Alaska Native people were posted on ClinicalTrials.gov on 2025-11-19, indicating increased screening rates with high-intensity intervention.
Background
Colorectal cancer (CRC) screening rates among Alaska Native people have historically been low, with only 59% adequately screened, despite this population experiencing the highest reported incidence of CRC globally. The introduction of at-home multi-target stool DNA (MT-sDNA) screening tests, such as Cologuard®, offers a new approach with high sensitivity for detecting pre-cancerous polyps and CRC. This study aimed to assess the feasibility and acceptability of MT-sDNA within the Alaska tribal health care delivery system and determine if its use could improve CRC screening rates in this specific population.
Trial design
This completed study, designated as Phase NA, enrolled 2029 participants to investigate Colorectal Cancer screening. The trial explored the impact of different intensity interventions on screening rates, comparing a high-intensity arm, a medium-intensity arm, and a usual care arm. The intervention involved the use of a new at-home multi-target stool DNA screening test (MT-sDNA; Cologuard®).
Key results
The trial reported several key measurements related to colorectal cancer screening:
- Colorectal Cancer Screening by Study Arm:
- Participants in the High Intensity arm who underwent screening: 205.
- Participants in the Medium Intensity arm who underwent screening: 165.
- Participants in the Usual Care arm who underwent screening: 32.
- Test Requested (MT-sDNA or Colonoscopy):
- High Intensity arm: 384 participants requested a test.
- Medium Intensity arm: 277 participants requested a test.
- High Intensity arm: 155 participants requested a test.
- Medium Intensity arm: 133 participants requested a test.
- MT-sDNA Diagnostic Follow-up:
- High Intensity arm: 29 participants completed diagnostic follow-up.
- Medium Intensity arm: 20 participants completed diagnostic follow-up.
Key analyses included:
- A Chi-squared analysis yielded an Odds Ratio (OR) of 1.2 (95% Confidence Interval: 1.0 to 1.5), with a p-value of 0.04.
- Another Chi-squared analysis reported a p-value of 0.01.
What this means
The results indicate that higher-intensity interventions were associated with increased colorectal cancer screening rates among Alaska Native people compared to usual care. The statistically significant Odds Ratio of 1.2 (95% CI: 1.0-1.5, p=0.04) suggests a positive effect of the intervention on screening uptake. These findings highlight the potential for targeted interventions, including the use of MT-sDNA tests, to improve CRC screening rates and address health disparities in this population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04336397, titled "Stool DNA to Improve Colorectal Cancer Screening Among Alaska Native People", were posted on 2025-11-19 on clinicaltrials.gov.