Blood screening test for colorectal cancer in adults
Official title: Evaluation of the Discriminatory Role of Blood TFPI-1 and TFPI-2 in Adult Colorectal Cancer
Run by University Hospital, Lille · NCT05577143 · Data updated 2026-11-12
This project will test whether the blood protein TFPI-1 can tell apart adults aged 50–75 who have colorectal cancer from people the same age with a normal colonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 303 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | March 23, 2023 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT05577143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 50–75 who are undergoing or scheduled for colonoscopy and are asymptomatic from a digestive standpoint or have suspected colorectal cancer.
✕Probably not a fit
People outside the 50–75 age range, those with conditions that elevate TFPI-1 (such as acute coronary syndrome, severe sepsis, or decompensated cirrhosis), or those already diagnosed with colorectal cancer may not receive benefit from this test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, inter-regional case-control study led by the University Hospital of Lille comparing blood TFPI-1 levels in patients with histologically confirmed colorectal cancer and asymptomatic controls aged 50–75 with normal colonoscopy. Adults referred for colonoscopy are enrolled and assigned to the control group if the post-inclusion colonoscopy is normal, or to the colorectal cancer or polyps group if lesions are found and confirmed by pathology. Blood samples will be analyzed to measure TFPI-1 and determine its ability to discriminate between groups. Patients with clinical conditions known to raise TFPI-1 (for example acute coronary syndrome, severe sepsis, or decompensated cirrhosis) are excluded.
Why it matters
Potential benefit: If successful, the test could provide a non-invasive blood signal to flag people who need further colon evaluation, supporting earlier detection of colorectal cancer.
How similar studies have gone: Other blood-based biomarker approaches for colorectal cancer (for example methylated DNA or protein markers) have shown promise, but TFPI-1 itself is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with suspected colorectal cancer for which colonoscopy is indicated. * Patients between 50 and 75 years old, asymptomatic from the digestive point of view (for example referred for colonoscopy as part of a pre-operative check-up of an inguinal hernia or 3 months after an episode of complicated sigmoiditis), for whom a follow-up colonoscopy is indicated. Note. * If the post-inclusion colonoscopy is normal, no biopsy will be performed and patients will be assigned to the control group. * If the colonoscopy performed after inclusion is abnormal (presence of at least one mucosal lesion), patients will be assigned to the "colorectal cancer" group or to the "polyps" group depending on the results of the anatomopathological analysis of the lesion(s) Exclusion Criteria: * All clinical situations outside of CRC that could increase TFPI-1 or 2 blood levels: acute coronary syndrome (unstable angina, acute myocardial infarction), severe sepsis, decompensated cirrhosis, pregnancy, chronic inflammatory bowel disease (Crohn's or ulcerative colitis), colitis or radiation rectitis. * Endoscopic polypectomy without prior histological confirmation. * Emergency (occlusion or peritonitis) * Minor patients. * Persons of full age under legal protection or unable to express their consent * Persons not affiliated to a social security system or beneficiaries of such a system. * Pregnant women, women in labor or nursing mothers.
Where it's running
-
Hôpital HURIEZ - Chirurgie digestive et transplantation
Lille, France Recruiting
Study contacts
- Principal investigator: Philippe ZERBIB, MD,PhD — University Hospital, Lille
- Study coordinator: Philippe ZERBIB, MD,PhD
- Email: philippe.zerbib@chru-lille.fr
- Phone: 0320445962
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Building Connections: improving cancer screening, weight management, and mental health for adults in vulnerable communities
This program will try to improve cancer screening, weight management, and mental health care for adults served by community clinics in Massachusetts.
-
Using blood tests to monitor colorectal cancer relapse and chemotherapy effectiveness
This study is testing a blood test that looks for cancer DNA to see if it can help track cancer coming back and how well chemotherapy works for people who had early-stage colorectal cancer.
-
French nationwide registry of colorectal endoscopic submucosal dissection at expert centers
We will collect outcomes from patients referred for colorectal endoscopic submucosal dissection (ESD) at expert French centers to see how safe and effective ESD is for removing large superficial colorectal lesions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.