Health TrialsbyHealthPanel

Blood Screening for Adult Colorectal Cancer

ConditionCancer Colorectal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity Hospital, Lille

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

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)

Disqualifiers

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.

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

303 Participants
are grouped into 3 trial groups
Group A: Case group
Group B: Control group
Group C: Polyp group

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Ministry of Health, France

Collaborator

Source ClinicalTrials.gov
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