Clinical trial NCT06515821: Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods
Official title: Multicentre Observational Study for the Data Collection, Development and Evaluation of the Performance of Novel CRC Screening and Diagnostic Methods ONCOSCREEN-CS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Keywords: early CRC detection
biomarkers
diagnostic tool
high risk subject
colorectal cancer
Lead sponsor: Firalis SA
Sponsor class: INDUSTRY
Collaborators: name: University Medical Center Mainz
First posted: 2024-07-23
Enrollment: 4100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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 outcomes:
measure: ONCO CTC expression pattern of ONCOSCREEN tools in CRC patients and healthy controls using colonoscopy as the reference method.
timeFrame: At the day of visit/sampling and through study completion, an average of 3 years
measure: ONCO NMR expression pattern
timeFrame: At Day1 and through study completion, an average of 3 years
measure: ONCO CRISPR expression pattern
timeFrame: At Day1 and through study completion, an average of 3 years
measure: ONCO VOC expression pattern
timeFrame: At Day1 and through study completion, an average of 3 years
measure: Evaluation of genetic risks associated to CRC
timeFrame: At Day1 and through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.
city: Brno
country: Czechia
facility: Masaryk Institute of Oncology
city: Besançon
country: France
facility: UFC: Université de Franche-Comté Oncology department CHU Besançon
city: Lübeck
country: Germany
facility: MKI UKSH Lübeck
city: Mainz-GE
country: Germany
facility: UMC Mainz: University Medical Center Mainz
city: Kaunas
country: Lithuania
facility: LSMU: Lithuanian University of Health Sciences Gastroenterology Department,
city: Porto
country: Portugal
facility: IPO: Instituto Português de Oncologia
city: Bucharest
country: Romania
facility: IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București
Study officials:
affiliation: University Medical Center Mainz
name: Markus MOELHER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: