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Blood Screening for Adult Colorectal Cancer

NCT ID: NCT05577143

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-23

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Colorectal

Keywords

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Oncology Biology

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case group

All consecutive patients from participating centers with an abnormal colonoscopy (presence of mucosal lesions at endoscopy), with histological confirmation of colorectal cancer. These will be patients with one or more histologically confirmed adenocarcinomatous lesions (CRC+) located in the colonic frame or rectum, with or without synchronous liver metastases.

No interventions assigned to this group

Control group

All consecutive patients between 50 and 75 years of age for whom colonoscopy will be normal (no mucosal lesions). In this situation, histological examination is not performed.

No interventions assigned to this group

Polyp group

All consecutive patients for whom colonoscopy shows mucosal lesions that will be classified as polyps after histological examination.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe ZERBIB, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital HURIEZ - Chirurgie digestive et transplantation

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe ZERBIB, MD,PhD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Facility Contacts

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philippe ZERBIB, Pr

Role: primary

Other Identifiers

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2022-A00223-40

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0220

Identifier Type: -

Identifier Source: org_study_id