AzTrials
AzTrials

Colorectal CancerMOCCASNCT02715141

Molecular Stool Testing for Colorectal Cancer Surveillance

An observational study of Colorectal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Collection of stool sample
How many people
3,966 participants
Where
1 siteNetherlands
Study dates
Oct 2015to 15 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Nethelands Cancer Institute

    Amsterdam, North Holland, 1066 CX

Other trials in Netherlands

About this study

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.

Read the detailed description

BACKGROUND: Since January 2014 the Dutch screening programme for colorectal carcinoma (CRC) has been implemented. Screening will increase the demand for surveillance. However, 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 patient burden and high costs. Therefore, there is need for new surveillance strategies. Stool-based molecular testing (Cologuard®) or Faecal Immunochemical Testing (FIT) may serve as an alternative for colonoscopy surveillance.

OBJECTIVES:

  1. 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.
  2. To model various strategies of stool-based molecular surveillance to inform health policy decisions.

MATERIALS AND METHODS: In this prospective observational cross-sectional cohort study, individuals aged 50-75 years that are scheduled for surveillance colonoscopy will be invited to participate. They are asked to collect a whole-stool sample prior to the surveillance colonoscopy. The sample will be used to test for the presence of molecular stool markers. The results of the molecular stool test and FIT will be compared to the colonoscopy findings.

EXPECTED RESULTS: Frequent surveillance using stool-based molecular testing is more cost-effective than the current colonoscopy-based surveillance.

Being tested
Collection of stool sample
Keywords
surveillance, molecular stool testing
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of stool sampleBehavioural

    Collection of stool sample prior to the scheduled surveillance colonoscopy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: 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)

  1. risk of CRC

    Risk factors for detecting advanced colonic neoplasia have been identified, of which the most established include gender, age, BMI, family history, physical activity, nutritional habits and smoking. Participants will be asked to complete a validated online questionnaire evaluating these risk factors.

    Measured: up to one month after surveillance colonoscopy

  2. presence of Cologuard marker pannel on resected tissue of polyps

    A challenge associated with the use of molecular markers is to find a panel of markers that represents the heterogeneity of the tumour. Therefore it is of interest to analyse whether the markers included in the Cologuard are present in the tissue of resected polyps.

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

  3. presence of previously identified progression biomarker on resected tissue samples of polyps

    The identification of biomarkers involved in the progression from colorectal adenoma to carcinoma (progression biomarkers) could aid better risk-stratification of adenomas and thereby decrease over-diagnosis and over-treatment . As a secondary objective we will therefore analyse previously identified progression biomarkers in the tissue samples of polyps obtained during colonoscopy.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2020
  4. Study completion15 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,966 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715141
Sponsor's protocol ID
M15MOC
Other IDs
NL52708.018.15
Acronym
MOCCAS
Status last verified
Jan 2022
First submitted
17 Feb 2016
Last updated
25 Jan 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39218164

  • 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.

    PubMed 28173852

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

accuracy of molecular stool test (Cologuard) and FIT (time frame: Patient inclusion for the calculation of the accuracies is expected to take 2-3 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715141, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in