Liquid Biopsy for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid (BLADE)

NCT ID: NCT06090214

Last Updated: 2023-10-19

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-12-01

Brief Summary

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The role of this transversal study is to assess the specificity and sensitivity of liquid biopsy to detect circulating cells tumor of adenocarcinoma of the ethmoid.

Blood sample of participants will be collected at the moment of the surgical procedure or recurrence diagnosis; immediately after surgery; at day 8-10; at month 2-3 of postoperative follow-up.

Two comparison groups will be studied: one age and gender-matched group and one professional exposure-matched group to assess the sensitivity and specificity of liquid biopsy

Detailed Description

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Conditions

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Ethmoid Sinus Tumor Adenocarcinoma Circulating Tumor Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The subjects will be included in the 3 following groups :

Group 1 : Patients: n=14 Group 2 : Controls, exposed to the same occupational risks n=14 Group 3 : unexposed controls n=14
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cases: adenocarcinoma of the ethmoid Group1

Liquid biopsy at the inclusion (V0), d8-d10 (V1) and m2-m3 (V2) of postoperative follow-up.

Group Type EXPERIMENTAL

Liquid biopsy

Intervention Type DIAGNOSTIC_TEST

For cases: 60 mL blood sample (40 ml for CellSave analysis and 20ml for collection) at visit1 then 20 ml for CellSave analysis at visit2 and visit3 For controls: 40 ml (20ml for CellSave analysis and 20ml for collection) at visit1

Age-matched controls Group 2

Liquid biopsy at the inclusion (V0) only

Group Type ACTIVE_COMPARATOR

Liquid biopsy

Intervention Type DIAGNOSTIC_TEST

For cases: 60 mL blood sample (40 ml for CellSave analysis and 20ml for collection) at visit1 then 20 ml for CellSave analysis at visit2 and visit3 For controls: 40 ml (20ml for CellSave analysis and 20ml for collection) at visit1

Exposition-matched controls Group 3

Liquid biopsy at the inclusion (V0) only

Group Type ACTIVE_COMPARATOR

Liquid biopsy

Intervention Type DIAGNOSTIC_TEST

For cases: 60 mL blood sample (40 ml for CellSave analysis and 20ml for collection) at visit1 then 20 ml for CellSave analysis at visit2 and visit3 For controls: 40 ml (20ml for CellSave analysis and 20ml for collection) at visit1

Interventions

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Liquid biopsy

For cases: 60 mL blood sample (40 ml for CellSave analysis and 20ml for collection) at visit1 then 20 ml for CellSave analysis at visit2 and visit3 For controls: 40 ml (20ml for CellSave analysis and 20ml for collection) at visit1

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Case group: diagnosis of adenocarcinoma of the ethmoid on biopsy or imaging recurence; age\>/= 18 years; patient consent ;
* Age and gender-matched control group: consulting patient in otolaryngology head and neck surgery department without adenocarcinoma of the ethmoid; no personal history of cancer; no familial history of colorectal adenocarcinoma;
* Exposition control group: Professional exposition to wood dust, leaver or nickel for at least 12 months; consulting patient in otolaryngology head and neck surgery department without adenocarcinoma of the ethmoid; no personal history of cancer; no familial history of colorectal adenocarcinoma;

Exclusion Criteria

* patient presenting with another malignant tumor
* deprivation of liberty
* patient under guardianship
* Other cancer diagnosed or under treatment
* Recurrent patient previously included in the study
* Refusal to accept the monitoring described and/or to provide the information required for the study
* No affiliation or non-beneficiary of a Social Security system;
* Pregnant or breast-feeding women in accordance with article L1121-5 of the Public Health Code (CSP)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GEFLUC Occitanie

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Valentin Favier, MD, PhD

Role: CONTACT

+33467336803

Other Identifiers

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RECHMPL22_0025

Identifier Type: -

Identifier Source: org_study_id

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