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Not yet recruitingNCT06090214BLADEUpdated Oct 19, 2023

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

An interventional study of Liquid biopsy in Ethmoid Sinus Tumor, Adenocarcinoma and Circulating Tumor Cell, sponsored by University Hospital, Montpellier. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Ethmoid Sinus Tumor
  • Adenocarcinoma
  • Circulating Tumor Cell
03

In context

Adenocarcinoma

620 studies on the registry are indexed under Adenocarcinoma; 148 are open to participants now.

This study's planned enrollment of 42 is below the median of 57 across 490 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Case group: diagnosis of adenocarcinoma of the ethmoid on 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

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Cases: adenocarcinoma of the ethmoid Group1

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

    Diagnostic Test: Liquid biopsy

  • Active comparator
    Age-matched controls Group 2

    Liquid biopsy at the inclusion (V0) only

    Diagnostic Test: Liquid biopsy

  • Active comparator
    Exposition-matched controls Group 3

    Liquid biopsy at the inclusion (V0) only

    Diagnostic Test: Liquid biopsy

Interventions

  • Diagnostic testLiquid 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

06

What researchers measure

Primary outcomes

  1. Number of circulating tumor cell

    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 outcomes

  1. Number of postoperative circulating tumor cell release

    Change of number circulating tumor cells detection in the liquid biopsy after surgery

    Time frame: At the surgery

  2. Tumor Node Metastasis (TNM) classification

    Description of TNM classification

    Time frame: Day 0

  3. Tumor diagnosis

    Primary diagnosis or tumor recurrence

    Time frame: Day 0

  4. Histological subtype

    Description of histological subtype

    Time frame: Day 0

  5. 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

    Time frame: at the surgery, day7, month3

  6. Estimated tumour volume

    Estimated tumour volume by imaging

    Time frame: Day 0

  7. Location of tumour site

    Location of tumour site (clinical, during surgery) to be plotted on a diagram

    Time frame: Day 0

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2023; primary completion for Sep 2025, 21 months later.

Of 40 interventional studies with no phase under Adenocarcinoma, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 170. This study's planned 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2023
First posted
Oct 19, 2023
StartEst.
Dec 1, 2023
Primary completionEst.
Sep 1, 2025
CompletionEst.
Dec 1, 2025
Last update
Oct 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06090214
Collaborators
GEFLUC Occitanie
Responsible party
Sponsor
First posted
Oct 19, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
Sep 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Oct 19, 2023

Study contacts

Valentin Favier, MD, PhD
Contact
v-favier@chu-montpellier.fr
+33467336803

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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