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.
Colorectal Cancer (CRC) is the third most commonly occurring cancer in men and the second most commonly occurring cancer in women. CRC can often be prevented through regular screening. Although colonoscopy-based screening programs result in a significant decrease in CRC incidence, the compliance rate for performing the required screening remains too low and not the desired one. Fecal Occult Blood Test (FOBT) is another widely used screening modality for CRC but have certain constraints, such as relatively low sensitivity and the need for multiple sampling (three) to reach full screening potential. The development of novel, more practical screening methods can effectively increase the screening rates for CRC through non-invasive, repeatable, cost-effective, easy-to-use, and patient-friendly procedures. This is of particular importance in different European societies and population subgroups, since an increase in the incidence of Early-Onset CRC is currently noticed, which is significantly associated with risk factors such as heredity, obesity, smoking, alcohol abuse, and hyperlipidemia. 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.
Study Type
OBSERVATIONAL
Enrollment
4,100
Subjects samples will be tested with diagnostic tests.
Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria
Sofia, Bulgaria
RECRUITINGUniversity Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.
Sofia, Bulgaria
NOT_YET_RECRUITINGONCO CTC expression pattern of ONCOSCREEN tools in CRC patients and healthy controls using colonoscopy as the reference method.
Blood samples will be collected to assess various novel biomarkers associated with CRC.
Time frame: At the day of visit/sampling and through study completion, an average of 3 years
ONCO NMR expression pattern
Blood samples will be collected to assess various novel biomarkers associated with CRC.
Time frame: At Day1 and through study completion, an average of 3 years
ONCO CRISPR expression pattern
Blood and stool samples will be collected to assess various novel biomarkers associated with CRC.
Time frame: At Day1 and through study completion, an average of 3 years
ONCO VOC expression pattern
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.
Time frame: At Day1 and through study completion, an average of 3 years
Evaluation of genetic risks associated to CRC
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.
Time frame: At Day1 and through study completion, an average of 3 years
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UFC: Université de Franche-Comté Oncology department CHU Besançon
Besançon, France
NOT_YET_RECRUITINGMKI UKSH Lübeck
Lübeck, Germany
RECRUITINGUMC Mainz: University Medical Center Mainz
Mainz-GE, Germany
RECRUITINGLSMU: Lithuanian University of Health Sciences Gastroenterology Department,
Kaunas, Lithuania
RECRUITINGIPO: Instituto Português de Oncologia
Porto, Portugal
RECRUITINGIBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București
Bucharest, Romania
NOT_YET_RECRUITING