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RecruitingNCT05577143BACCHUSUpdated May 22, 2026

Blood Screening for Adult Colorectal Cancer

An observational study in Cancer Colorectal, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University Hospital, Lille · Observational

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
303
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Multicenter, inter-regional, case-control study with the primary objective of evaluating the discriminative power of the blood biomarker TFPI-1 to separate patients with histologically proven CRC from an asymptomatic control population between 50 and 75 years of age with normal colonoscopy.

02

Conditions studied

  • Cancer Colorectal

Keywords

  • Oncology
  • Biology
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's planned enrollment of 303 is close to the median of 280 across 349 observational studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients followed up for colonoscopy in the gastroenterology and digestive surgery departments of 5 regional hospitals in northern France

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
303 participants (estimated)
Patient registry
No

Groups and cohorts

  • Case group

    All consecutive patients from participating centers with an abnormal colonoscopy (presence of mucosal lesions at endoscopy), with histological confirmation of colorectal cancer. These will be patients with one or more histologically confirmed adenocarcinomatous lesions (CRC+) located in the colonic frame or rectum, with or without synchronous liver metastases.

  • Control group

    All consecutive patients between 50 and 75 years of age for whom colonoscopy will be normal (no mucosal lesions). In this situation, histological examination is not performed.

  • Polyp group

    All consecutive patients for whom colonoscopy shows mucosal lesions that will be classified as polyps after histological examination.

06

What researchers measure

Primary outcomes

  1. Area under the ROC curve (AUC) of the TFPI-1 biomarker

    the AUC of the TFPI-1 biomarker to separate the 2 groups (CRC+ and control, i.e., asymptomatic population between 50 and 75 years with normal colonoscopy).

    Time frame: At 2 months

Secondary outcomes

  1. AUC of the TFPI-2 biomarker to separate the 2 groups (CRC+ and control).

    Time frame: At 2 months

  2. AUC of the discriminant score constructed by logistic regression with the 2 blood biomarkers as explanatory variables and the group type (CRC+ and control) as the variable to be explained.

    Time frame: At 2 months

  3. Extension of c-index to the 3-group case proposed by Van Calster B et al.

    Time frame: At 2 months

07

Study locations

1 of 1 sites recruiting
  • Hôpital HURIEZ - Chirurgie digestive et transplantation
    Lille, France
    • philippe ZERBIB, Pr · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05577143
Lead sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Oct 13, 2022
Start date
Mar 23, 2023
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
May 22, 2026

Study contacts

Philippe ZERBIB, MD,PhD
Contact
philippe.zerbib@chru-lille.fr
0320445962 ext. +33
Philippe ZERBIB, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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