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

Primary Purpose

Ethmoid Sinus Tumor, Adenocarcinoma, Circulating Tumor Cell

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Liquid biopsy
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ethmoid Sinus Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Cases: adenocarcinoma of the ethmoid Group1

    Age-matched controls Group 2

    Exposition-matched controls Group 3

    Arm Description

    Liquid biopsy at the inclusion (V0), d8-d10 (V1) and m2-m3 (V2) of postoperative follow-up.

    Liquid biopsy at the inclusion (V0) only

    Liquid biopsy at the inclusion (V0) only

    Outcomes

    Primary Outcome Measures

    Number of circulating tumor cell
    Presence of at least 1 circulating tumor cell in the liquid biopsies

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 5, 2023
    Last Updated
    October 18, 2023
    Sponsor
    University Hospital, Montpellier
    Collaborators
    GEFLUC Occitanie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06090214
    Brief Title
    Liquid Biopsy for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid (BLADE)
    Acronym
    BLADE
    Official Title
    Circulating Tumor Cells for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid : a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2025 (Anticipated)
    Study Completion Date
    December 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier
    Collaborators
    GEFLUC Occitanie

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ethmoid Sinus Tumor, Adenocarcinoma, Circulating Tumor Cell

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cases: adenocarcinoma of the ethmoid Group1
    Arm Type
    Experimental
    Arm Description
    Liquid biopsy at the inclusion (V0), d8-d10 (V1) and m2-m3 (V2) of postoperative follow-up.
    Arm Title
    Age-matched controls Group 2
    Arm Type
    Active Comparator
    Arm Description
    Liquid biopsy at the inclusion (V0) only
    Arm Title
    Exposition-matched controls Group 3
    Arm Type
    Active Comparator
    Arm Description
    Liquid biopsy at the inclusion (V0) only
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Liquid biopsy
    Intervention 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
    Primary Outcome Measure Information:
    Title
    Number of circulating tumor cell
    Description
    Presence of at least 1 circulating tumor cell in the liquid biopsies
    Time Frame
    Day0, Day 7 to 10, VMonth 3 for patients ; Day 0 for controls
    Secondary Outcome Measure Information:
    Title
    Number of postoperative circulating tumor cell release
    Description
    Change of number circulating tumor cells detection in the liquid biopsy after surgery
    Time Frame
    At the surgery
    Title
    Tumor Node Metastasis (TNM) classification
    Description
    Description of TNM classification
    Time Frame
    Day 0
    Title
    Tumor diagnosis
    Description
    Primary diagnosis or tumor recurrence
    Time Frame
    Day 0
    Title
    Histological subtype
    Description
    Description of histological subtype
    Time Frame
    Day 0
    Title
    Presence of Circulating Tumor Cells (CTCs) in at least one of the patient's peripheral samples
    Description
    Presence of CTCs in at least one of the patient's peripheral samples
    Time Frame
    at the surgery, day7, month3
    Title
    Estimated tumour volume
    Description
    Estimated tumour volume by imaging
    Time Frame
    Day 0
    Title
    Location of tumour site
    Description
    Location of tumour site (clinical, during surgery) to be plotted on a diagram
    Time Frame
    Day 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Valentin Favier, MD, PhD
    Phone
    +33467336803
    Email
    v-favier@chu-montpellier.fr

    12. IPD Sharing Statement

    Learn more about this trial

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

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