Clinical trial NCT06090214: Liquid Biopsy for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid (BLADE)
Official title: Circulating Tumor Cells for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid : a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ethmoid Sinus Tumor
Adenocarcinoma
Circulating Tumor Cell
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: GEFLUC Occitanie
First posted: 2023-10-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

Brief summary: 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


Eligibility criteria: 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)

Primary outcomes:
measure: Number of circulating tumor cell
timeFrame: Day0, Day 7 to 10, VMonth 3 for patients ; Day 0 for controls
Secondary outcomes:
measure: Number of postoperative circulating tumor cell release
timeFrame: At the surgery
measure: Tumor Node Metastasis (TNM) classification
timeFrame: Day 0
measure: Tumor diagnosis
timeFrame: Day 0
measure: Histological subtype
timeFrame: Day 0
measure: Presence of Circulating Tumor Cells (CTCs) in at least one of the patient's peripheral samples
timeFrame: at the surgery, day7, month3
measure: Estimated tumour volume
timeFrame: Day 0
measure: Location of tumour site
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
References: