Clinical trial NCT05577143: Blood Screening for Adult Colorectal Cancer
Official title: Evaluation of the Discriminatory Role of Blood TFPI-1 and TFPI-2 in Adult Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Colorectal
Keywords: Oncology
Biology
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2022-10-13
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


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.

Primary outcomes:
measure: Area under the ROC curve (AUC) of the TFPI-1 biomarker
timeFrame: At 2 months
Secondary outcomes:
measure: AUC of the TFPI-2 biomarker to separate the 2 groups (CRC+ and control).
timeFrame: At 2 months
measure: 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.
timeFrame: At 2 months
measure: Extension of c-index to the 3-group case proposed by Van Calster B et al.
timeFrame: At 2 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Philippe ZERBIB, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: