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Trial Title:
Blood Screening for Adult Colorectal Cancer
NCT ID:
NCT05577143
Condition:
Cancer Colorectal
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Oncology
Biology
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients followed up for colonoscopy in the gastroenterology and digestive surgery
departments of 5 regional hospitals in northern France
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 2022
Completion date:
October 2024
Lead sponsor:
Agency:
University Hospital, Lille
Agency class:
Other
Collaborator:
Agency:
Ministry of Health, France
Agency class:
Other
Source:
University Hospital, Lille
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05577143
