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

Adenocarcinoma Clinical Trial

— BLADE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06090214
• Other study ID #: RECHMPL22_0025
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Circulating Tumor Cell
• Neoplasms
• Neoplastic Cells, Circulating

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