Adenocarcinoma Clinical Trial
— BLADEOfficial title:
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
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | GEFLUC Occitanie |
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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