Blood screening test for colorectal cancer in adults

Evaluation of the Discriminatory Role of Blood TFPI-1 and TFPI-2 in Adult Colorectal Cancer

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
• Enrollment: 303 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Lille (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Lille)
• Trial ID: NCT05577143 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Lille

• 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

Conditions Cancer Colorectal; Oncology; Biology