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Clinical Trials in Portugal / NCT06515821
Recruiting Observational

Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods

NCT06515821 · tracked via the Priya Life Science Portugal tracker
Sponsor
Phase
Observational
Started
2024-08-01
Last updated
2026-09-16

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

ONCOSCREEN

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)

Trial sites (8)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06515821 on ClinicalTrials.gov ↗ ← All trials in Portugal