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Studying new tests to detect colon cancer early in people at high risk

Studies new low-cost tests for colon cancer detection in high-risk adults across Europe.

Key facts

Who runs it
Firalis SA
Where
Besançon, FranceSee the siteAlso in 5 other countries, 7 sites
Trial code
Registry title
Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods
Status
Recruiting
People taking part
4,100 people, planned
Started
1 Aug 2024
Expected to end
31 Dec 2026
Type of study
Observational, 4 groups
Treatments tested
  • ONCOSCREEN
Record updated
16 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with colorectal cancer, and for control groups with or without risk factors for colorectal cancer, to test new screening and diagnostic methods.

Age
18 years or older. The control group with no risk factors must be 40 years or older.
Sex
All sexes can join.
Disease stage
One group has colorectal cancer confirmed by colonoscopy. The control groups have a negative colonoscopy result, or a negative FOBT result if they have no risk factors.
Earlier treatment
People with colorectal cancer cannot have had surgery in the previous 6-8 weeks or be on medication for colorectal cancer treatment.
Biomarker or test result
Control group with no risks: negative FOBT result. Other groups: willing to have an FOBT test, colonoscopy and tissue biopsy.

Main reasons for not taking part

  • Legal incapacity or limited legal capacity
  • Did not sign the informed consent form
  • Unstable medical condition that rules out the planned blood, stool or breath test (colorectal cancer group)
  • Any previous cancer (control groups)
  • Gastrointestinal disorders or other serious acute or chronic diseases (control groups)

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • CRC Group; Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study; Subjects aged ≥18 years; Subject is willing to undergo FOBT test, colonoscopy, and tissue biopsy; Subject for whom the decision to perform a colonoscopy has been made by the treating physician; Subject has positive CRC diagnosis according to colonoscopy result; Covered by a Health Insurance System; Subject is able to comply with all study procedures
  • Control Group with risks and presence of polyps; Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study; Subjects aged ≥18 years; Otherwise healthy individuals with recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidaemia; Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy; Subject has negative CRC diagnosis according to colonoscopy result; Covered by a Health Insurance System, which will cover colonoscopy as screening in patients with risk factors and alarm symptoms such as abdominal pain, change in stool texture, change in stool frequency, blood in stool/rectal bleeding, diarrhea, constipation, abdominal bloating, weight loss, tiredness
  • Control Group with risks and absence of polyps; Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study; Subjects aged ≥18 years; Otherwise healthy individuals with recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidaemia; Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy; Subject has negative CRC diagnosis according to colonoscopy result; Covered by a Health Insurance System, which will cover colonoscopy as screening in patients with risk factors and alarm symptoms such as abdominal pain, change in stool texture, change in stool frequency, blood in stool/rectal bleeding, diarrhea, constipation, abdominal bloating, weight loss, tiredness
  • Control Group with no risks; Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study; Subjects aged ≥40 years; Otherwise healthy individuals without any recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidemia; Subject be willing to undergo FOBT test; Subject has negative FOBT result

Who cannot take part

  • For the CRC Group; Legal incapacity or limited legal capacity; Subject did not sign the Informed Consent form; Subject who, according to the investigator's assessment, presents with an unstable medical condition contraindicating the performance of the planned blood test, stool test or breath test; Subject has had surgery in the previous 6-8 weeks or is under medication for CRC treatment
  • For the control groups; Legal incapacity or limited legal capacity; Subject did not sign the Informed Consent form; Previous history of any type of cancer; Gastrointestinal disorders or other serious acute or chronic diseases

Where in France

Also in 5 other countries, 7 sites

  • UFC: Université de Franche-Comté Oncology department CHU BesançonBesançon, FranceContact: Christophe BORG, MDNot yet recruiting

About the trial

What the trial wants to find out

The primary goal is to develop easy accessible diagnostic tools for high risk subjects for colon cancer in different European populations to improve early CRC detection. These CRC screening technologies would be low cost, breakthrough and of high sensitivity and specificity.

The 4 groups in the trial

  • CRC Group

    Subject has positive CRC diagnosis according to colonoscopy result

    Treatment: ONCOSCREEN

  • Control Group with risks and presence of polyps

    Healthy individuals with recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidaemia.

    Treatment: ONCOSCREEN

  • Control Group with risks and absence of polyps

    Healthy individuals with recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidaemia.

    Treatment: ONCOSCREEN

  • Control Group with no risks

    Healthy individuals without any recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidemia.

    Treatment: ONCOSCREEN

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Multicentre Observational Study for the Data Collection, Development and Evaluation of the Performance of Novel CRC Screening and Diagnostic Methods ONCOSCREEN-CS
Plain-language title
Studying new tests to detect colon cancer early in people at high riskGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
16 September 2026