An observational study in Colorectal Cancer, sponsored by Firalis SA. Recruiting at 8 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Firalis SA · Observational
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Among 22 studies in Colorectal Neoplasms with a site in Bulgaria — 2 open to participants now, 4 under way, 3 of them phase 3. Colorectal Neoplasms · Bulgaria.
Among the 22 studies in Colorectal Neoplasms with a site in Bulgaria, this one is one of 2 that started in 2024, is the only observational one, and was the 22nd registered.
6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.
Browse Colorectal Neoplasms studies →2 of the 22 studies in Colorectal Neoplasms with a site in Bulgaria are open now. Recruiting first, the newest first:
Amgen · Sites in Bulgaria, United States, Argentina and 32 more countries
Ages 18+
A study can be open while its sites in Bulgaria have not opened yet or have stopped. Only those recruiting at a site in Bulgaria →
Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 7 · Phase 3 11 · Phase 4 2
First in 2004; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 4,100 is above the median of 250 across 1,442 observational studies indexed under Colorectal Neoplasms.
Median enrollment 232 across the 21 interventional studies, 4,100 across the 1 observational. Of the 18 that completed or were terminated, 10 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 22 have an industry lead sponsor. The 10 most frequent:
Firalis SA is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Firalis SA has 1 study filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies in Colorectal Neoplasms with a site in Bulgaria that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06515821Firalis SAMulticentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods | 2026-12-31 |
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Among the 22 studies in Colorectal Neoplasms with a site in Bulgaria, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Subjects aged over 18 for all groups except the control group with no risk where in this group subjects are aged ≥ 40 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
CRC Group
Control Group with risks and presence of polyps
Control Group with risks and absence of polyps
Control Group with no risks
Exclusion Criteria:
For the CRC Group
For the control groups
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject has positive CRC diagnosis according to colonoscopy result
Diagnostic Test: 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.
Diagnostic Test: 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.
Diagnostic Test: 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.
Diagnostic Test: ONCOSCREEN
Subjects samples will be tested with diagnostic tests.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Day1 and through study completion, an average of 3 years
Plan to share: No
Started Aug 2024 (actual). Primary completion is estimated for Dec 2026, 28 months after the start.
Of 117 industry-sponsored observational studies under Colorectal Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 60. This study's planned 28 months is below that.
Counting every sponsor, half of 646 studies reached it within 52 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Firalis SA