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

University Hospital, Montpellier0 sites42 target enrollmentDecember 1, 2023

ConditionsEthmoid Sinus Tumor Adenocarcinoma Circulating Tumor Cell

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ethmoid Sinus Tumor
Sponsor: University Hospital, Montpellier
Enrollment: 42
Primary Endpoint: Number of circulating tumor cell
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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

Registry

clinicaltrials.gov

Start Date

December 1, 2023

End Date

December 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

Number of circulating tumor cell

Time Frame: 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 Outcomes

Tumor Node Metastasis (TNM) classification(Day 0)
Tumor diagnosis(Day 0)
Location of tumour site(Day 0)
Number of postoperative circulating tumor cell release(At the surgery)
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)
Estimated tumour volume(Day 0)