Developing new methods for early detection of colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to create accessible and effective diagnostic tools for early detection of colorectal cancer (CRC) in high-risk individuals across various European populations. It addresses the limitations of current screening methods, such as colonoscopy and fecal occult blood tests, by focusing on developing non-invasive, cost-effective, and user-friendly screening technologies. The study will also consider socio-economic factors that contribute to CRC risk, particularly in younger populations. Participants will include both diagnosed CRC patients and healthy individuals with risk factors for CRC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* CRC Group

  1. 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.
  2. Subjects aged ≥18 years
  3. Subject is willing to undergo FOBT test, colonoscopy, and tissue biopsy
  4. Subject for whom the decision to perform a colonoscopy has been made by the treating physician
  5. Subject has positive CRC diagnosis according to colonoscopy result
  6. Covered by a Health Insurance System
  7. Subject is able to comply with all study procedures
* Control Group with risks and presence of polyps

  1. 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.
  2. Subjects aged ≥18 years
  3. 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.
  4. Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy
  5. Subject has negative CRC diagnosis according to colonoscopy result
  6. 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

  1. 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.
  2. Subjects aged ≥18 years
  3. 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.
  4. Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy
  5. Subject has negative CRC diagnosis according to colonoscopy result
  6. 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

  1. 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.
  2. Subjects aged ≥40 years
  3. 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.
  4. Subject be willing to undergo FOBT test
  5. Subject has negative FOBT result

Exclusion Criteria:

* For the CRC Group

  1. Legal incapacity or limited legal capacity
  2. Subject did not sign the Informed Consent form
  3. 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
  4. Subject has had surgery in the previous 6-8 weeks or is under medication for CRC treatment.
* For the control groups

  1. Legal incapacity or limited legal capacity
  2. Subject did not sign the Informed Consent form
  3. Previous history of any type of cancer
  4. Gastrointestinal disorders or other serious acute or chronic diseases

Where it's running

• Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria
  Sofia, Bulgaria Recruiting
• MKI UKSH Lübeck
  Lübeck, Germany Recruiting
• UMC Mainz: University Medical Center Mainz
  Mainz-GE, Germany Recruiting
• LSMU: Lithuanian University of Health Sciences Gastroenterology Department,
  Kaunas, Lithuania Recruiting
• IPO: Instituto Português de Oncologia
  Porto, Portugal Recruiting
• University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.
  Sofia, Bulgaria Not yet recruiting

Study contacts

• Principal investigator: Markus MOELHER, MD, PhD — University Medical Center Mainz
• Study coordinator: Federica ZILLI, PhD
• Email: federica.zilli@firalis.com
• Phone: +33 (0) 389911320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.