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

September 14, 2026 updated by: Firalis SA

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 (Estimated)

4100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1797
        • Not yet recruiting
        • University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.
        • Contact:
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria
        • Contact:
          • Daniela Stoyanova, Prof. Dr.
  • France
      • Besançon, France, 25030
        • Not yet recruiting
        • UFC: Université de Franche-Comté Oncology department CHU Besançon
        • Contact:
  • Germany
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Recruiting
        • LSMU: Lithuanian University of Health Sciences Gastroenterology Department,
        • Contact:
        • Contact:
          • Laurynas Jarukas
  • Portugal
  • Romania
      • Bucharest, Romania
        • Not yet recruiting
        • IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects aged over 18 for all groups except the control group with no risk where in this group subjects are aged ≥ 40 years.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CRC Group
Subject has positive CRC diagnosis according to colonoscopy result
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: ONCOSCREEN
Subjects samples will be tested with diagnostic tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ONCO CTC expression pattern of ONCOSCREEN tools in CRC patients and healthy controls using colonoscopy as the reference method.
Time Frame: 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.
At the day of visit/sampling and through study completion, an average of 3 years
ONCO NMR expression pattern
Time Frame: At Day1 and through study completion, an average of 3 years
Blood samples will be collected to assess various novel biomarkers associated with CRC.
At Day1 and through study completion, an average of 3 years
ONCO CRISPR expression pattern
Time Frame: 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.
At Day1 and through study completion, an average of 3 years
ONCO VOC expression pattern
Time Frame: 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.
At Day1 and through study completion, an average of 3 years
Evaluation of genetic risks associated to CRC
Time Frame: 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.
At Day1 and through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firalis SA

Collaborators

University Medical Center Mainz

Investigators

  • Principal Investigator: Markus MOELHER, MD, PhD, University Medical Center Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A01793-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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