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Recruiting

NCT Number: NCT05577143

Blood Screening for Adult Colorectal Cancer

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital HURIEZ - Chirurgie digestive et transplantation

Lille, France

Location status: Recruiting

Location contact

philippe ZERBIB, Pr

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: At 2 months

    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).

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

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe ZERBIB, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: BACCHUS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 13, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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