Developing new methods for early detection of colorectal cancer

Multicentre Observational Study for the Data Collection, Development and Evaluation of the Performance of Novel CRC Screening and Diagnostic Methods ONCOSCREEN-CS

This study is trying to create easier and cheaper ways to detect colorectal cancer early in people at high risk across Europe.

Quick facts

• Study type: Observational
• Enrollment: 4100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Firalis SA (Industry-sponsored)
• Locations: 8 sites (Sofia and 7 other locations)
• Trial ID: NCT06515821 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 and older who are either diagnosed with colorectal cancer or have recognized risk factors such as heredity, obesity, or smoking.

Not a fit: Patients without any risk factors for colorectal cancer or those who are not willing to undergo the required screening procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve early detection rates of colorectal cancer, leading to better patient outcomes.

How similar studies have performed: Other studies have shown promise in developing novel screening methods for colorectal cancer, indicating that this approach has potential for success.

Eligibility criteria

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 this trial is running

Sofia and 7 other locations

• Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria — Sofia, Bulgaria (Recruiting)
• University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology. — Sofia, Bulgaria (Not_yet_recruiting)
• UFC: Université de Franche-Comté Oncology department CHU Besançon — Besançon, France (Not_yet_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)
• IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București — Bucharest, Romania (Not_yet_recruiting)

Study contacts

• Principal investigator: Markus MOELHER, MD, PhD — University Medical Center Mainz
• Study coordinator: Federica ZILLI, PhD

Conditions Colorectal Cancer; early CRC detection; biomarkers; diagnostic tool; high risk subject; colorectal cancer