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

University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Ethmoid Sinus Tumor; Circulating Tumor Cell; Adenocarcinoma

Treatments: Diagnostic Test: Liquid biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06090214

RECHMPL22_0025

Details and patient eligibility

About

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

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Cases: adenocarcinoma of the ethmoid Group1

Experimental group

Description:

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

Treatment:

Diagnostic Test: Liquid biopsy

Age-matched controls Group 2

Active Comparator group

Description:

Liquid biopsy at the inclusion (V0) only

Treatment:

Diagnostic Test: Liquid biopsy

Exposition-matched controls Group 3

Active Comparator group

Description:

Liquid biopsy at the inclusion (V0) only

Treatment:

Diagnostic Test: Liquid biopsy