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Fecal DNA testing improved colorectal cancer screening rates compared to immunochemical testing in primary careFecal DNA test boosts colorectal cancer screening rates in community clinics

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Key Takeaway
Consider fecal DNA testing to improve colorectal cancer screening uptake over immunochemical testing in primary care.

This pragmatic cluster randomized clinical trial evaluated colorectal cancer screening uptake among English- or Spanish-speaking primary care patients aged 45 to 75 years due for screening. The study compared a mailed fecal immunochemical test with automated text message outreach to a mailed fecal DNA test using the manufacturer's standard outreach protocol. The trial took place in community health centers across Massachusetts, California, and South Dakota.

The primary outcome measured screening participation using any modality within 90 days. Results showed higher participation rates in the fecal DNA group compared to the fecal immunochemical test group at both 90 and 180 days. Additionally, screening participation was higher in Boston sites compared to Los Angeles sites.

Secondary outcomes included screening within 180 days and completion of follow-up colonoscopy. The authors observed that the rate of follow-up colonoscopy within six months of an abnormal stool test result was suboptimal, even when navigation support was available. No adverse events or discontinuations were reported.

The authors conclude that fecal DNA testing yielded higher screening uptake than fecal immunochemical testing in this community setting. They caution that while the DNA test improved initial participation, the overall follow-up colonoscopy rate remained low, suggesting a need for further strategies to address the diagnostic gap after positive stool tests.

Colorectal cancer screening saves lives, but many people do not get tested. This research matters for patients in community health centers who might struggle to find time or motivation for screening. The study looked at whether a newer test could help more people get screened. It also tested if automated text messages could encourage participation.

Researchers conducted a pragmatic cluster randomized clinical trial. They enrolled 5,127 English- or Spanish-speaking primary care patients aged 45 to 75 years. These patients were due for colorectal cancer screening. The study took place in community health centers in the greater Boston area in Massachusetts, Los Angeles County in California, and Rapid City, South Dakota.

Participants were divided into two groups. One group received a mailed fecal immunochemical test, known as FIT, along with outreach from study personnel. The other group received a mailed fecal DNA test, known as FIT-DNA, using the manufacturer's standard outreach protocol. The primary goal was to see if more people would complete screening within 90 days using any method, including FIT, FIT-DNA, or colonoscopy.

The results showed higher screening participation in the FIT-DNA group compared to the FIT group. Within 90 days, 27.9 percent of patients in the FIT-DNA group participated versus 22.6 percent in the FIT group. This difference was statistically significant with a p-value of .02. When looking at participation within 180 days, the FIT-DNA group reached 31.7 percent while the FIT group reached 26.7 percent. The study also found that screening participation was higher in Boston compared to Los Angeles.

Safety was not a major concern in this trial. No adverse events, serious adverse events, discontinuations, or tolerability issues were reported. However, the study did note a limitation regarding follow-up care. Only 36 percent of patients completed a follow-up colonoscopy within 180 days of an abnormal stool test result. This rate was considered suboptimal even when navigation support was available.

People should not overreact to this single study. The evidence comes from a cluster randomized clinical trial, which is a strong design, but the study has specific limitations. The lower follow-up colonoscopy rate suggests that getting patients through the entire screening process remains a challenge. This study does not prove that FIT-DNA is better than colonoscopy for finding cancer. It only shows that the FIT-DNA test with text message outreach led to higher initial screening rates in this specific setting.

For patients right now, this means that newer stool tests might be an option to consider if you are due for screening. The availability of automated text message outreach might also help remind you to schedule your appointment. However, the best screening method for you depends on your doctor's advice and your personal health history. Talk to your primary care provider about which screening test is right for you.

What this means for you:
A fecal DNA test with text messages increased colorectal cancer screening rates compared to a standard fecal test in this trial.

Study Details

Study typeRct
Sample sizen = 5,127
EvidenceLevel 2
Follow-up900.0 mo
PublishedJun 2026
View Original Abstract ↓
IMPORTANCE: Colorectal cancer (CRC) is the second most common cause of cancer mortality in the US and disproportionately impacts individuals in underresourced settings. OBJECTIVE: To compare 2 mailed population outreach approaches to increase CRC screening uptake among screening-eligible adults in community health centers (CHCs). DESIGN, SETTING, AND PARTICIPANTS: This pragmatic cluster randomized clinical trial was conducted in 8 CHCs and an additional site in a nonrandomized parallel protocol. The CHCs were located in the greater Boston area in Massachusetts and Los Angeles County in California (randomized sites), and Rapid City, South Dakota (parallel site). Patients were enrolled in the trial between June 7, 2023, and October 24, 2023. English- or Spanish-speaking primary care patients aged 45 to 75 years, who were due for CRC screening, were eligible to participate. INTERVENTIONS: Patients received either mailed fecal immunochemical test (FIT) with automated text message outreach from study personnel or mailed FIT-DNA with the manufacturer's outreach protocol. Participants in Boston and Los Angeles (randomized sites) with an abnormal FIT or FIT-DNA result were offered standardized navigation to colonoscopy. MAIN OUTCOMES AND MEASURES: The primary outcome was CRC screening participation using any modality (FIT, FIT-DNA, or colonoscopy) within 90 days. Secondary outcomes were screening within 180 days and time to screening participation. The completion of follow-up colonoscopy within 180 days of an abnormal stool test result was also studied. RESULTS: Among 5127 participants in the RCT regions, 2435 (47.5%) were in the FIT group, and 2692 (52.5%) were in the FIT-DNA group. The mean (SD) age was 54.5 (8.1) years; 3018 (58.9%) were female, and 2109 (41.1%) were male. There were 3818 Hispanic individuals (74.5%), 369 non-Hispanic Black individuals (7.2%), 763 non-Hispanic White individuals (14.9%), and 58 individuals of another race (1.1%). A total of 3363 individuals (65.6%) preferred the Spanish language; 2540 (49.5%) were Medicaid insured, and 614 were (12.0%) uninsured. Screening participation was significantly higher in the FIT-DNA group vs the FIT group at 90 days (751 of 2692 [27.9%] vs 550 of 2435 [22.6%], respectively; P = .02) and 180 days (854 of 2692 [31.7%] vs 649 of 2435 [26.7%], respectively). In Boston, screening participation at 90 days was higher (628 of 2208 [28.4%]) than in Los Angeles (673 of 2919 [23.1%]). Findings were similar at 180 days. Among the 100 individuals with an abnormal stool test result, 36 (36.0%) completed a colonoscopy within 180 days. CONCLUSIONS AND RELEVANCE: In this cluster randomized clinical trial, CRC screening uptake was higher in the FIT-DNA group than in the FIT group and was higher in Boston compared to Los Angeles CHCs. The follow-up colonoscopy rate within 6 months was suboptimal, even with the availability of navigation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05714644.
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