Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods
NCT ID: NCT06515821
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4100 participants
OBSERVATIONAL
2024-08-01
2026-12-31
Brief Summary
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Detailed Description
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Within this framework, ONCOSCREEN will develop a multi-tier diagnostic solution towards improved CRC screening. Furthermore, ONCOSCREEN will consider specific socio-economic determinants which increase the regional or national CRC risks, thus exploiting new solutions, particularly in younger high-risk individuals in European communities. For the validation of the developed solution, a clinical validation study (titled "ONCOSCREEN-CS") will be conducted to assess its effectiveness, sensitivity, and specificity in detecting CRC at an early stage. During the first phase of the study (ONCOSCREEN-CS-Phase A), the investigators will identify the different expression patterns of the four diagnostic solutions (ONCO-VOC, ONCO-CRISP, ONCO-NMR, ONCO-CTC) in CRC patients and healthy controls with high risk for CRC, and also initially estimate their sensitivity and specificity. During the second phase (ONCOSCREEN-CS-Phase B), the ONCOSCREEN solution will be clinically validated.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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CRC Group
Subject has positive CRC diagnosis according to colonoscopy result
ONCOSCREEN
Subjects samples will be tested with diagnostic tests.
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.
ONCOSCREEN
Subjects samples will be tested with diagnostic tests.
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.
ONCOSCREEN
Subjects samples will be tested with diagnostic tests.
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.
ONCOSCREEN
Subjects samples will be tested with diagnostic tests.
Interventions
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ONCOSCREEN
Subjects samples will be tested with diagnostic tests.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University Medical Center Mainz
OTHER
Firalis SA
INDUSTRY
Responsible Party
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Principal Investigators
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Markus MOELHER, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Mainz
Locations
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Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria
Sofia, , Bulgaria
University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.
Sofia, , Bulgaria
UFC: Université de Franche-Comté Oncology department CHU Besançon
Besançon, , France
MKI UKSH Lübeck
Lübeck, , Germany
UMC Mainz: University Medical Center Mainz
Mainz-GE, , Germany
LSMU: Lithuanian University of Health Sciences Gastroenterology Department,
Kaunas, , Lithuania
IPO: Instituto Português de Oncologia
Porto, , Portugal
IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București
Bucharest, , Romania
Countries
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Central Contacts
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Facility Contacts
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Daniela Stoyanova, Prof. Dr.
Role: primary
Laurynas Jarukas
Role: backup
Related Links
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Website of the clinical study
Other Identifiers
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2023-A01793-42
Identifier Type: -
Identifier Source: org_study_id
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