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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06090214
Other study ID # RECHMPL22_0025
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 1, 2025

Study information

Verified date October 2023
Source University Hospital, Montpellier
Contact Valentin Favier, MD, PhD
Phone +33467336803
Email v-favier@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 42
Est. completion date December 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Montpellier GEFLUC Occitanie

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of postoperative circulating tumor cell release Change of number circulating tumor cells detection in the liquid biopsy after surgery At the surgery
Secondary Tumor Node Metastasis (TNM) classification Description of TNM classification Day 0
Secondary Tumor diagnosis Primary diagnosis or tumor recurrence Day 0
Secondary Histological subtype Description of histological subtype Day 0
Secondary 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
Secondary Estimated tumour volume Estimated tumour volume by imaging Day 0
Secondary Location of tumour site Location of tumour site (clinical, during surgery) to be plotted on a diagram Day 0
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