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

Study Overview
=================
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

Official Title
-----------------
Circulating Tumor Cells for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid : a Pilot Study

Conditions
-----------------
Ethmoid Sinus Tumor, Adenocarcinoma, Circulating Tumor Cell

Intervention / Treatment
-----------------
* Diagnostic Test: Liquid biopsy


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cases: adenocarcinoma of the ethmoid Group1<br>Liquid biopsy at the inclusion (V0), d8-d10 (V1) and m2-m3 (V2) of postoperative follow-up. | Diagnostic Test: Liquid biopsy<br>* 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<br>|
| Active Comparator: Age-matched controls Group 2<br>Liquid biopsy at the inclusion (V0) only | Diagnostic Test: Liquid biopsy<br>* 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<br>|
| Active Comparator: Exposition-matched controls Group 3<br>Liquid biopsy at the inclusion (V0) only | Diagnostic Test: Liquid biopsy<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of circulating tumor cell | Presence of at least 1 circulating tumor cell in the liquid biopsies | Day0, Day 7 to 10, VMonth 3 for patients ; Day 0 for controls | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of postoperative circulating tumor cell release | Change of number circulating tumor cells detection in the liquid biopsy after surgery | At the surgery | 
| Tumor Node Metastasis (TNM) classification | Description of TNM classification | Day 0 | 
| Tumor diagnosis | Primary diagnosis or tumor recurrence | Day 0 | 
| Histological subtype | Description of histological subtype | Day 0 | 
| Presence of Circulating Tumor Cells (CTCs) in at least one of the patient's peripheral samples | Presence of CTCs in at least one of the patient's peripheral samples | at the surgery, day7, month3 | 
| Estimated tumour volume | Estimated tumour volume by imaging | Day 0 | 
| Location of tumour site | Location of tumour site (clinical, during surgery) to be plotted on a diagram | Day 0 |