Blood Screening for Adult Colorectal Cancer

Cancer Colorectal Clinical Trial

— BACCHUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05577143
• Other study ID #: 2021_0220
• Secondary ID: 2022-A00223-40
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: October 2024

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Philippe ZERBIB, MD,PhD
• Phone: 0320445962
• Email: philippe.zerbib[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 303
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Colorectal
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AUC of the TFPI-2 biomarker to separate the 2 groups (CRC+ and control).		At 2 months
Secondary	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
Secondary	Extension of c-index to the 3-group case proposed by Van Calster B et al.		At 2 months