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

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Diagnostic Test: ONCOSCREEN

• Registration Number: NCT06515821
• Lead Sponsor: Firalis SA

Brief 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.

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 Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group with risks and presence of polyps	ONCOSCREEN	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.
Control Group with no risks	ONCOSCREEN	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.
CRC Group	ONCOSCREEN	Subject has positive CRC diagnosis according to colonoscopy result
Control Group with risks and absence of polyps	ONCOSCREEN	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (8)

UMC Mainz: University Medical Center Mainz; 🇩🇪 Mainz-GE, Germany

University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.; 🇧🇬 Sofia, Bulgaria

Masaryk Institute of Oncology; 🇨🇿 Brno, Czechia

UFC: Université de Franche-Comté Oncology department CHU Besançon; 🇫🇷 Besançon, France

MKI UKSH Lübeck; 🇩🇪 Lübeck, 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