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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Adenocarcinoma; Circulating Tumor Cell; Ethmoid Sinus Tumor
• Intervention / Treatment: Diagnostic test: Liquid biopsy

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valentin Favier, MD, PhD; Phone Number: +33467336803; Email: v-favier@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: GEFLUC Occitanie

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Neoplasm Metastasis; Neoplasms; Adenocarcinoma; Neoplastic Cells, Circulating
• Other Study ID Numbers: RECHMPL22_0025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No