Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
Br J Cancer. 2023 Sep;129(5):791-796. doi: 10.1038/s41416-023-02358-z. Epub 2023 Jul 19.
Combining the faecal immunochemical test (FIT) result with risk factors for advanced neoplasia (AN) may increase the yield of colorectal cancer (CRC) screening without increasing the number of colonoscopies. We conducted a randomised controlled trial in the Dutch CRC screening programme to evaluate a previously developed risk model including FIT, age, sex, smoking status, and CRC family history.
A total of 22,748 individuals aged 56-75 years were pre-randomised to the risk-model group or the FIT-only group. Both groups received the FIT; those allocated to the risk-model group also received a single-page questionnaire. Study participants with a positive result (FIT ≥ 15 µg Hb/g faeces and/or risk ≥0.10) were referred for colonoscopy. The primary outcome measure was the proportion of invitees in whom AN was detected.
In the risk-model group, 3113/11,364 invitees (27%) returned the FIT and questionnaire versus 3061/11,384 invitees (27%) in the FIT-only group (p = 0.40). The yield of AN was 3.70/1000 invitees in the risk-model group versus 3.43/1000 in the FIT-only group (absolute difference: 0.27/1000, 95%CI: -1.30 to 1.82, p = 0.82).
Combining FIT with risk factors for CRC did not increase the yield of AN compared to FIT-only in an existing CRC screening programme. There was no difference in participation between groups.
NCT04490551 (ClinicalTrials.gov).
将粪便免疫化学检测（FIT）结果与高级别肿瘤（AN）的风险因素相结合，可能会增加结直肠癌（CRC）筛查的检出率，而不会增加结肠镜检查的数量。我们在荷兰 CRC 筛查项目中进行了一项随机对照试验，以评估一种以前开发的风险模型，该模型包括 FIT、年龄、性别、吸烟状况和 CRC 家族史。
共有 22748 名年龄在 56-75 岁的个体进行了预随机分组，分为风险模型组或仅 FIT 组。两组均接受 FIT；分配到风险模型组的个体还接受了一份单页问卷。检测结果阳性（FIT≥15μg Hb/g 粪便和/或风险≥0.10）的研究参与者被转介行结肠镜检查。主要结局测量指标是 AN 检出者的比例。
在风险模型组中，11364 名受邀者中有 3113 人（27%）返回了 FIT 和问卷，而在仅 FIT 组中，11384 名受邀者中有 3061 人（27%）（p=0.40）。风险模型组中 AN 的检出率为每 1000 名受邀者 3.70 例，而仅 FIT 组为每 1000 名受邀者 3.43 例（绝对差异：0.27/1000，95%CI：-1.30 至 1.82，p=0.82）。
与仅 FIT 相比，在现有的 CRC 筛查项目中，将 FIT 与 CRC 的风险因素相结合并未增加 AN 的检出率。两组之间的参与率没有差异。
NCT04490551（ClinicalTrials.gov）。
