Malignant Pharyngo Laryngeal TumorsMEC ORLNCT01626638
Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL)
A study testing Confocal Micro Endoscopy in people with Malignant Pharyngo Laryngeal Tumors and Pre-malignant Pharyngo Laryngeal Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.
Trial summary
The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pharyngo Laryngeal Tumors, Pre-malignant Pharyngo Laryngeal Tumors
- What is being tested?
- Confocal Micro Endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Feb 2013to 24 May 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal
- > 18 years
- signed ICF
Who cannot join
- Persons deprived of liberty
- Patients with history of allergy to patent blue
- Pregnant women or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse
Institut Gustave Roussy
Villejuif, Val De Marne, 94805
About this study
Official title: Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer
The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.
- Being tested
- Confocal Micro Endoscopy
- Keywords
- Patients with malignant and pre-malignant pharyngo laryngeal tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal Micro EndoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Procedure: Confocal Micro Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic correlation between confocal micro endoscopy and conventional histology
Measured: at an average of 18 months
Secondary outcomes (1)
Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis
Measured: At the time of the biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study start1 Feb 2013
- Primary completion24 May 2017
- Study completion24 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Pharyngo Laryngeal TumorsStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Stéphane TEMAM, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626638
- Sponsor's protocol ID
- 2011-A00818-33
- Acronym
- MEC ORL
- Status last verified
- Feb 2021
- First submitted
- 15 Jun 2012
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Villard A, Breuskin I, Casiraghi O, Asmandar S, Laplace-Builhe C, Abbaci M, Moya Plana A. Confocal laser endomicroscopy and confocal microscopy for head and neck cancer imaging: Recent updates and future perspectives. Oral Oncol. 2022 Apr;127:105826. doi: 10.1016/j.oraloncology.2022.105826. Epub 2022 Mar 19.
PubMed 35316771
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01626638
- Acronym / sponsor ID
- MEC ORL / 2011-A00818-33
- Keywords
- Patients with malignant and pre-malignant pharyngo laryngeal tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 25 Jun 2012 (estimated)
- 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 primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Confocal Micro Endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal
- > 18 years
- signed ICF
Key exclusion criteria (3 listed)
- Persons deprived of liberty
- Patients with history of allergy to patent blue
- Pregnant women or breastfeeding women
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 |
|---|---|---|
| Confocal Micro Endoscopy | Procedure or surgery | Experimental |
Primary outcome
Diagnostic correlation between confocal micro endoscopy and conventional histology
Time frame: at an average of 18 months
1 secondary outcome
Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis
Time frame: At the time of the biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 35316771Villard A, Breuskin I, Casiraghi O, Asmandar S, Laplace-Builhe C, Abbaci M, Moya Plana A. Confocal laser endomicroscopy and confocal microscopy for head and neck cancer imaging: Recent updates and future perspectives. Oral Oncol. 2022 Apr;127:105826. doi: 10.1016/j.oraloncology.2022.105826. Epub 2022 Mar 19.
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.
Stéphane TEMAM, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal Micro Endoscopy in people with Malignant Pharyngo Laryngeal Tumors and Pre-malignant Pharyngo Laryngeal Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.
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 3 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: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic correlation between confocal micro endoscopy and conventional histology (time frame: at an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01626638, which also lists 1 linked publication.
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 18 Feb 2021.