ONCOSCREEN: Subjects samples will be tested with diagnostic tests.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
ONCO CTC expression pattern of ONCOSCREEN tools in CRC patients and healthy controls using colonoscopy as the reference method. — At the day of visit/sampling and through study completion, an average of 3 years Blood samples will be collected to assess various novel biomarkers associated with CRC.
ONCO NMR expression pattern — At Day1 and through study completion, an average of 3 years Blood samples will be collected to assess various novel biomarkers associated with CRC.
ONCO CRISPR expression pattern — At Day1 and through study completion, an average of 3 years Blood and stool samples will be collected to assess various novel biomarkers associated with CRC.
ONCO VOC expression pattern — At Day1 and through study completion, an average of 3 years Breath samples will be collected to analyze volatile organic compounds (VOCs). By examining the electrochemical signal responses using pattern recognition algorithms, researchers can identify early indicators distinguishing between CRC-linked and healthy categories.
Evaluation of genetic risks associated to CRC — At Day1 and through study completion, an average of 3 years Buccal swabs will be collected to evaluate genetic risks associated to CRC. Analyzing buccal swab samples can identify genetic variations linked to an increased CRC risk, enhancing personalized screening accuracy.
Trial sites (8)
Facility
City
Region
Status
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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