Colorectal CancerNCT06515821
Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods
An observational study of Colorectal Cancer, run by Firalis SA at 8 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- ONCOSCREEN
- How many people
- 4,100 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- CRC Group
- 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.
- Subjects aged ≥18 years
- Subject is willing to undergo FOBT test, colonoscopy, and tissue biopsy
- Subject for whom the decision to perform a colonoscopy has been made by the treating physician
- Subject has positive CRC diagnosis according to colonoscopy result
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- Covered by a Health Insurance System
- Subject is able to comply with all study procedures
- Control Group with risks and presence of polyps
- 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.
- Subjects aged ≥18 years
- 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.
- Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy
- Subject has negative CRC diagnosis according to colonoscopy result
- 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
- 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.
- Subjects aged ≥18 years
- 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.
- Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy
- Subject has negative CRC diagnosis according to colonoscopy result
- 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
- 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.
- Subjects aged ≥40 years
- 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.
- Subject be willing to undergo FOBT test
- Subject has negative FOBT result
Who cannot join
- For the CRC Group
- Legal incapacity or limited legal capacity
- Subject did not sign the Informed Consent form
- 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
- Subject has had surgery in the previous 6-8 weeks or is under medication for CRC treatment.
- For the control groups
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- Legal incapacity or limited legal capacity
- Subject did not sign the Informed Consent form
- Previous history of any type of cancer
- Gastrointestinal disorders or other serious acute or chronic diseases
Trial locations and contacts
8 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Céline Meyer contact
8 sites in 6 countries
Bulgaria2 sites, 2 recruiting
- Recruiting
Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria
Sofia, 1606
Daniela Stoyanova, Prof. Dr.
- Not yet recruiting
University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.
Sofia, 1797
Bozhidar TOMOV, MD, btomov@sbaloncology.bg
Germany2 sites, 2 recruiting
- Recruiting
MKI UKSH Lübeck
Lübeck, 23538
Jens MARQUARDT, MD, jens.marquardt@uksh.de
Annette Benderschiffer, annette.benderschiffer@uni-luebeck.de
- Recruiting
UMC Mainz: University Medical Center Mainz
Mainz-GE, 55131
Markus MOEHLER, Prof. Dr., markus.moehler@unimedizin-mainz.de
Markus MOEHLER, Prof. Dr.
France1 site, 1 recruiting
- Not yet recruiting
UFC: Université de Franche-Comté Oncology department CHU Besançon
Besançon, 25030
Christophe BORG, MD, +(33) 0 6 13 88 01 61, xtoph.borg@gmail.com
Lithuania1 site, 1 recruiting
- Recruiting
LSMU: Lithuanian University of Health Sciences Gastroenterology Department,
Kaunas, 50161
Juozas KUPCINSKAS, MD, juozas.kupcinskas@lsmuni.lt
Laurynas Jarukas
Portugal1 site, 1 recruiting
- Recruiting
IPO: Instituto Português de Oncologia
Porto, 4200-072
Mário DINIS RIBEIRO, MD, mario.ribeiro@ipoporto.min-saude.pt
Alda SILVA, gabinetedeprojetos@ipoporto.min-saude.pt
Romania1 site, 1 recruiting
- Not yet recruiting
IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București
Bucharest
Geanina Papuc, MD, papucgeanina@iob.ro
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- ONCOSCREEN
- Keywords
- early CRC detection, biomarkers, diagnostic tool, high risk subject, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONCOSCREENDiagnostic test
Subjects samples will be tested with diagnostic tests.
| Study group | Role | What they receive |
|---|---|---|
| CRC Group | Subject has positive CRC diagnosis according to colonoscopy result Receives: Diagnostic Test: ONCOSCREEN | |
| 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. Receives: Diagnostic Test: ONCOSCREEN | |
| 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. Receives: Diagnostic Test: ONCOSCREEN | |
| 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. Receives: Diagnostic Test: ONCOSCREEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
ONCO 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day1 and through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firalis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Medical Center Mainz
- Responsible party
- Sponsor
- Investigators
- Markus MOELHER, MD, PhD, Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515821
- Sponsor's protocol ID
- 2023-A01793-42
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Observational Study for the Data Collection, Development and Evaluation of the Performance of Novel CRC Screening and Diagnostic Methods ONCOSCREEN-CS
- ClinicalTrials.gov ID
- NCT06515821
- Acronym / sponsor ID
- 2023-A01793-42
- Conditions
- Colorectal Cancer
- Keywords
- early CRC detection, biomarkers, diagnostic tool, high risk subject, colorectal cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- Firalis SAIndustry (pharma, biotech, devices)
- Collaborators
- University Medical Center Mainz
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CRC Group | – | Diagnostic Test: ONCOSCREENSubject has positive CRC diagnosis according to colonoscopy result |
| Control Group with risks and presence of polyps | – | Diagnostic Test: ONCOSCREENHealthy 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 risks and absence of polyps | – | Diagnostic Test: ONCOSCREENHealthy 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 | – | Diagnostic Test: ONCOSCREENHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (28 listed)
- CRC Group
- Control Group with risks and presence of polyps
- Control Group with risks and absence of polyps
- Control Group with no risks
Key exclusion criteria (10 listed)
- For the CRC Group
- For the control groups
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONCOSCREENSubjects samples will be tested with diagnostic tests. | Diagnostic test | CRC Group, Control Group with no risks, Control Group with risks and absence of polyps, Control Group with risks and presence of polyps |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Website of the clinical studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Céline Meyer contact
Markus MOELHER, MD, PhD principal investigator
University Medical Center Mainz
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Firalis SA at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Bulgaria, Germany, France, Lithuania, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federica ZILLI, PhD (+33 (0) 389911320, federica.zilli@firalis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.