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

Not Applicable

Not yet recruiting

• Conditions: Circulating Tumor Cell; Ethmoid Sinus Tumor; Adenocarcinoma
• Interventions: Diagnostic Test: Liquid biopsy

• Registration Number: NCT06090214
• Lead Sponsor: University Hospital, Montpellier

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-19
• Last Update Posted: 2023-10-19
• Study Start: 2023-12-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exposition-matched controls Group 3	Liquid biopsy	Liquid biopsy at the inclusion (V0) only
Cases: adenocarcinoma of the ethmoid Group1	Liquid biopsy	Liquid biopsy at the inclusion (V0), d8-d10 (V1) and m2-m3 (V2) of postoperative follow-up.
Age-matched controls Group 2	Liquid biopsy	Liquid biopsy at the inclusion (V0) only

Primary Outcome Measures

Name	Time	Method
Number of circulating tumor cell	Day0, Day 7 to 10, VMonth 3 for patients ; Day 0 for controls	Presence of at least 1 circulating tumor cell in the liquid biopsies

Secondary Outcome Measures

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