NCT05577143

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

October 10, 2022

Last Update Submit

December 18, 2025

Conditions

Cancer Colorectal

Keywords

OncologyBiology

Outcome Measures

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).

    At 2 months

Secondary Outcomes (3)

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

    At 2 months

  • 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.

    At 2 months

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

    At 2 months

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital HURIEZ - Chirurgie digestive et transplantation

Lille, France

RECRUITING

MeSH Terms

Conditions

Colonic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Philippe ZERBIB, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe ZERBIB, MD,PhD

CONTACT

0320445962philippe.zerbib@chru-lille.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

March 23, 2023

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations

FR(1)