Ethmoid Sinus TumorBLADENCT06090214
Liquid Biopsy for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid (BLADE)
A study testing Liquid biopsy in people with Ethmoid Sinus Tumor and Adenocarcinoma, run by University Hospital, Montpellier.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ethmoid Sinus Tumor, Adenocarcinoma, Circulating Tumor Cell
- What is being tested?
- Liquid biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official 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
- Conditions
- Ethmoid Sinus Tumor, Adenocarcinoma, Circulating Tumor Cell
- Being tested
- Liquid biopsy
- Medical subject headings
- Adenocarcinoma, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid biopsyDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Cases: adenocarcinoma of the ethmoid Group1 | Experimental | Liquid biopsy at the inclusion (V0), d8-d10 (V1) and m2-m3 (V2) of postoperative follow-up. Receives: Diagnostic Test: Liquid biopsy |
| Age-matched controls Group 2 | Active comparator | Liquid biopsy at the inclusion (V0) only Receives: Diagnostic Test: Liquid biopsy |
| Exposition-matched controls Group 3 | Active comparator | Liquid biopsy at the inclusion (V0) only Receives: Diagnostic Test: Liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating tumor cell
Presence of at least 1 circulating tumor cell in the liquid biopsies
Measured: Day0, Day 7 to 10, VMonth 3 for patients ; Day 0 for controls
Secondary outcomes (7)
Number of postoperative circulating tumor cell release
Change of number circulating tumor cells detection in the liquid biopsy after surgery
Measured: At the surgery
Tumor Node Metastasis (TNM) classification
Description of TNM classification
Measured: Day 0
Tumor diagnosis
Primary diagnosis or tumor recurrence
Measured: Day 0
Histological subtype
Description of histological subtype
Measured: Day 0
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
Measured: at the surgery, day7, month3
Estimated tumour volume
Estimated tumour volume by imaging
Measured: Day 0
Location of tumour site
Location of tumour site (clinical, during surgery) to be plotted on a diagram
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ethmoid Sinus TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- GEFLUC Occitanie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090214
- Sponsor's protocol ID
- RECHMPL22_0025
- Acronym
- BLADE
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid : a Pilot Study
- ClinicalTrials.gov ID
- NCT06090214
- Acronym / sponsor ID
- BLADE / RECHMPL22_0025
- Conditions
- Ethmoid Sinus Tumor, Adenocarcinoma, Circulating Tumor Cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- GEFLUC Occitanie
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Cases: adenocarcinoma of the ethmoid Group1 | Experimental | Diagnostic Test: Liquid biopsyLiquid biopsy at the inclusion (V0), d8-d10 (V1) and m2-m3 (V2) of postoperative follow-up. |
| Age-matched controls Group 2 | Active comparator | Diagnostic Test: Liquid biopsyLiquid biopsy at the inclusion (V0) only |
| Exposition-matched controls Group 3 | Active comparator | Diagnostic Test: Liquid biopsyLiquid biopsy at the inclusion (V0) only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid biopsyFor 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 | Diagnostic test | Age-matched controls Group 2, Cases: adenocarcinoma of the ethmoid Group1, Exposition-matched controls Group 3 |
Primary outcome
Number of circulating tumor cell
Time frame: Day0, Day 7 to 10, VMonth 3 for patients ; Day 0 for controls
Presence of at least 1 circulating tumor cell in the liquid biopsies
7 secondary outcomes
Number of postoperative circulating tumor cell release
Time frame: At the surgery
Tumor Node Metastasis (TNM) classification
Time frame: Day 0
Tumor diagnosis
Time frame: Day 0
Histological subtype
Time frame: Day 0
Presence of Circulating Tumor Cells (CTCs) in at least one of the patient's peripheral samples
Time frame: at the surgery, day7, month3
Estimated tumour volume
Time frame: Day 0
Location of tumour site
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid biopsy in people with Ethmoid Sinus Tumor and Adenocarcinoma, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentin Favier, MD, PhD (+33467336803, v-favier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of circulating tumor cell (time frame: Day0, Day 7 to 10, VMonth 3 for patients ; Day 0 for controls). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.