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

NCT06090214 | Unknown

• 1 other identifier: RECHMPL22_0025
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ethmoid Sinus Tumor; Adenocarcinoma; Circulating Tumor Cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of postoperative circulating tumor cell release

  At the surgery

• Tumor Node Metastasis (TNM) classification

  Day 0

• Tumor diagnosis

  Day 0

• Histological subtype

  Day 0

• Presence of Circulating Tumor Cells (CTCs) in at least one of the patient's peripheral samples

  at the surgery, day7, month3

Study Arms (3)

Cases: adenocarcinoma of the ethmoid Group1

EXPERIMENTAL

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

Diagnostic Test: Liquid biopsy

Age-matched controls Group 2

ACTIVE COMPARATOR

Liquid biopsy at the inclusion (V0) only

Diagnostic Test: Liquid biopsy

Exposition-matched controls Group 3

ACTIVE COMPARATOR

Liquid biopsy at the inclusion (V0) only

Diagnostic Test: Liquid biopsy

Interventions

Liquid biopsy DIAGNOSTIC_TEST

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

Age-matched controls Group 2; Cases: adenocarcinoma of the ethmoid Group1; Exposition-matched controls Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• GEFLUC Occitanie: collaborator

MeSH Terms

Conditions

Adenocarcinoma; Neoplastic Cells, Circulating

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Central Study Contacts

Valentin Favier, MD, PhD

CONTACT

+33467336803; v-favier@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 19, 2023
• Study Start: December 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-10