To hear about similar clinical trials, please enter your email below
Trial Title:
Liquid Biopsy for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid (BLADE)
NCT ID:
NCT06090214
Condition:
Ethmoid Sinus Tumor
Adenocarcinoma
Circulating Tumor Cell
Conditions: Official terms:
Neoplasms
Adenocarcinoma
Neoplastic Cells, Circulating
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Liquid biopsy
Description:
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
Arm group label:
Age-matched controls Group 2
Arm group label:
Cases: adenocarcinoma of the ethmoid Group1
Arm group label:
Exposition-matched controls Group 3
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
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
December 1, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
University Hospital, Montpellier
Agency class:
Other
Collaborator:
Agency:
GEFLUC Occitanie
Agency class:
Other
Source:
University Hospital, Montpellier
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06090214
