Clinical trial · Observational
Molecular Stool Testing for Colorectal Cancer Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Rationale: Since January 2014 the Dutch screening programme for bowel cancer has been implemented. Screening will increase the demand for surveillance. Although patients in whom adenomas have been removed are at increased risk of progressing to cancer, solid evidence on the reduction of death from CRC through the current colonoscopy-based surveillance is lacking. Furthermore, colonoscopy-based surveillance leads to high logistic demands, high individual burden and high costs. Therefore, there is need for new surveillance strategies. Stool-based molecular testing (Cologuard®, consisting of a stool DNA test and an immunochemical assay for human hemoglobin) or Faecal Immunochemical Testing (FIT) may serve as an alternative for colonoscopy surveillance. The aim of this study is to compare the accuracy of an established molecular stool test (Cologuard®) and FIT to colonoscopy for detection of advanced adenomas or CRC (advanced neoplasia) in a surveillance population. These outcomes will be used to model various strategies of stool-based molecular surveillance to inform health policy decisions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of stool sample | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- accuracy of molecular stool test (Cologuard) and FIT
- timeFrame
- Patient inclusion for the calculation of the accuracies is expected to take 2-3 years.
- description
- The accuracy (sensitivity, specificity, PPV and NPV) of the molecular stool test (Cologuard®) and FIT compared to colonoscopy in the detection of advanced neoplasia in a surveillance population.
- measure
- cost-effectiveness of stool-based surveillance strategies using the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model
- timeFrame
- This will be calculated when all accuracy data (outcome 1) are available. This is expected to be 6 months after end of study.
- description
- Cost-effectiveness of multiple surveillance strategies, using test performance data as input in the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model.
- measure
- life time health effects of stool-based surveillance strategies using the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model
- timeFrame
- This will be calculated when all accuracy data (outcome 1) are available. This is expected to be 6 months after end of study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
* Subjects in the age group 50-75 years. The lower age limit is set at 50 years because of the high probability of familiar predisposition when advanced neoplasm is present in a younger age group.26 The upper age limit of 75 years is in correspondence with the recommended stop-age for surveillance according to the current guideline.9
* Subjects with an indication for surveillance colonoscopy according to the previous guideline ('Follow up after polypectomy', 2002; summarized in 2008) or current ('Colonoscopy Surveillance', 2013) guideline. This includes subjects with a history of CRC or polypectomy, as well as subjects under surveillance for familial colorectal carcinoma (FCC).
* Subjects who have sufficient comprehension of the Dutch language.
* Subjects who have given their informed consent.
Exclusion criteria:
* Subjects with inflammatory bowel disease (IBD)
* Subjects with Lynch syndrome, familial adenomatous polyposis (FAP), attenuated FAP (AFAP), MUTYH associated polyposis (MAP) and serrated polyposis syndrome (SPS)
* Subjects with a previous colonoscopy \< 6 months (rescopy)
* Subjects with proctocolectomy
* Subjects with life expectancy \< 3 yearsReferences
Publications (2)
- DERIVEDCarvalho B, de Klaver W, van Wifferen F, van Lanschot MCJ, van Wetering AJP, van der Zander QEW, Lemmens M, Bolijn AS, Tijssen M, Delis-van Diemen P, Buekers N, Daenen K, van der Meer J, van Mulligen PG, Hijmans BS, de Ridder S, Meiqari L, Bierkens M, van der Hulst RWM, Kuyvenhoven JPH, van Berkel AM, Depla ACTM, van Leerdam ME, Jansen JM, Wientjes CA, Straathof JWA, Keulen ETP, Ramsoekh D, Moons LMG, Zacherl M, Masclee AAM, de Wit M, Greuter MJE, van Engeland M, Dekker E, Coupe VMH, Meijer GA. Stool-Based Testing for Post-Polypectomy Colorectal Cancer Surveillance Safely Reduces Colonoscopies: The MOCCAS Study. Gastroenterology. 2025 Jan;168(1):121-135.e16. doi: 10.1053/j.gastro.2024.08.022. Epub 2024 Aug 30. PMID 39218164
- DERIVEDvan Lanschot MC, Carvalho B, Coupe VM, van Engeland M, Dekker E, Meijer GA. Molecular stool testing as an alternative for surveillance colonoscopy: a cross-sectional cohort study. BMC Cancer. 2017 Feb 7;17(1):116. doi: 10.1186/s12885-017-3078-y. PMID 28173852