NCT02715141

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,966

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

5.2 years

First QC Date

February 17, 2016

Last Update Submit

January 24, 2022

Conditions

Colorectal Cancer

Keywords

surveillance, molecular stool testing

Outcome Measures

Primary Outcomes (3)

  • accuracy of molecular stool test (Cologuard) and FIT

    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.

    Patient inclusion for the calculation of the accuracies is expected to take 2-3 years.

  • cost-effectiveness of stool-based surveillance strategies using the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model

    Cost-effectiveness of multiple surveillance strategies, using test performance data as input in the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model.

    This will be calculated when all accuracy data (outcome 1) are available. This is expected to be 6 months after end of study.

  • life time health effects of stool-based surveillance strategies using the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model

    The ASCCA model will be used to predict outcomes, including cancer incidence and mortality, for different surveillance strategies.

    This will be calculated when all accuracy data (outcome 1) are available. This is expected to be 6 months after end of study.

Secondary Outcomes (3)

  • risk of CRC

    up to one month after surveillance colonoscopy

  • presence of Cologuard marker pannel on resected tissue of polyps

    Analysis will be performed during the study and approximately 1 year after end of study

  • presence of previously identified progression biomarker on resected tissue samples of polyps

    Analysis will be performed during the study and approximately 1 year after end of study

Interventions

Collection of stool sampleBEHAVIORAL

Collection of stool sample prior to the scheduled surveillance colonoscopy.

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The intended population of this study consists all subjects in the participating centres that are elected for colonoscopy surveillance.

You may qualify if:

  • 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.

You may not qualify if:

  • 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 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nethelands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Related Publications (2)

  • Carvalho 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: 39218164DERIVED

  • van 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: 28173852DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples will be collected. The stool samples will be used to test for the presence of molecular stool markers.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2016

First Posted

March 22, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 15, 2020

Last Updated

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)