Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

NCT ID: NCT05520840

Last Updated: 2022-08-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-09-30

Brief Summary

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The aim of the study is to validate the value of value of peripheral blood protein biomarkers in colorectal cancer screening, and to identify new ones

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient referred for screening colonoscopy or for endoscopic resection

Patient aged 50 years or older referred for screening colonoscopy after a positive fecal immunochemical test or for endoscopic resection of a previously identified suspicious colorectal lesion will have a blood sampling for biomarkers detection

Group Type EXPERIMENTAL

blood sampling for screening of biomarkers

Intervention Type DIAGNOSTIC_TEST

Patient aged 50 years or older referred for screening colonoscopy after a positive fecal immunochemical test or for endoscopic resection of a previously identified suspicious colorectal lesion will have a blood sampling for biomarkers detection

Interventions

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blood sampling for screening of biomarkers

Patient aged 50 years or older referred for screening colonoscopy after a positive fecal immunochemical test or for endoscopic resection of a previously identified suspicious colorectal lesion will have a blood sampling for biomarkers detection

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient aged 50 years or older referred for screening colonoscopy after a positive FIT test or for endoscopic resection of a previously identified suspicious colorectal lesion

Exclusion Criteria

* Very high risk of colorectal cancer: Lynch syndrome, Familial adenomatous polyposis, Peutz-Jeghers syndrome, Familial polyposis associated with a MutYH gene defect
* Other solid cancers or haematological malignancies that are progressive and/or undergoing treatment (apart from basal cell skin carcinoma)
* Contraindication to total colonoscopy
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OncoDiag

UNKNOWN

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrien Grancher, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Clinique du Cèdre

Bois-Guillaume, , France

Site Status

Caen University Hospital

Caen, , France

Site Status

Dijon University Hospital

Dijon, , France

Site Status

Countries

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France

Central Contacts

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Adrien Grancher, MD

Role: CONTACT

+3323288 ext. 8610

Julien BLOT

Role: CONTACT

+3323288 ext. 8265

Facility Contacts

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Aude DI FIORE

Role: primary

Karine BOUHIER, MD

Role: primary

Sylvain MANFREDI, Pr

Role: primary

Other Identifiers

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2022/0149/HP

Identifier Type: -

Identifier Source: org_study_id

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