Supraglottic Squamous Cell CarcinomaNCT03357107
Local Control After Robot-assisted Supraglottic Laryngectomy
An observational study of Supraglottic Squamous Cell Carcinoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Transoral robotic surgery is an option to treat supraglottic squamous cell carcinomas. Oncological outcomes 2 years after transoral robotic surgery for supraglottic laryngectomy were studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraglottic Squamous Cell Carcinoma
- What is being tested?
- Transoral robotic surgery (TORS)
- Type of treatment
- Surgery or procedure
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2016to 28 Feb 2017
- Phase
- Observational
- 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
Study population: Patients with supraglottic squamous cell carcinoma who had undergone robot-assisted supraglottic laryngectomy and with at least 2 years follow-up
Who may be able to join
- Men or women over 18 years of age
- Patients with supra-glottic squamous cell carcinoma from T1 to T3, all stages N
- Patients with a robot assisted supra-glottic laryngectomy with at least 2 years follow-up
Who cannot join
- Patients for whom follow-up of at least 2 years has not been achieved;
- Major patients protected by the law (under guardianship or guardianship);
- Patients who expressed opposition to their participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Local Control 2 Years After Robot-assisted Supraglottic Laryngectomy: a Multicenter Retrospective Study
Transoral robotic surgery is an option to treat supraglottic squamous cell carcinomas. Oncological outcomes 2 years after transoral robotic surgery for supraglottic laryngectomy were studied.
- Conditions
- Supraglottic Squamous Cell Carcinoma
- Being tested
- Transoral robotic surgery (TORS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral robotic surgery (TORS)Procedure or surgery
All patients underwent primary tumour resection with transoral robotic surgery (TORS) using the daVinci robot (Intuitive Surgical, Sunnyvale CA)
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
Proportion of patients without cancer recurrence 2 years after surgery
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Oct 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357107
- Sponsor's protocol ID
- CRC_GHN_2017_009
- Status last verified
- Nov 2017
- First submitted
- 23 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Control 2 Years After Robot-assisted Supraglottic Laryngectomy: a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT03357107
- Acronym / sponsor ID
- CRC_GHN_2017_009
- Conditions
- Supraglottic Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 29 Nov 2017 (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.
Transoral robotic surgery is an option to treat supraglottic squamous cell carcinomas. Oncological outcomes 2 years after transoral robotic surgery for supraglottic laryngectomy were studied.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with supraglottic squamous cell carcinoma who had undergone robot-assisted supraglottic laryngectomy and with at least 2 years follow-up
Key inclusion criteria (3 listed)
- Men or women over 18 years of age
- Patients with supra-glottic squamous cell carcinoma from T1 to T3, all stages N
- Patients with a robot assisted supra-glottic laryngectomy with at least 2 years follow-up
Key exclusion criteria (3 listed)
- Patients for whom follow-up of at least 2 years has not been achieved;
- Major patients protected by the law (under guardianship or guardianship);
- Patients who expressed opposition to their participation 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 |
|---|---|---|
| Transoral robotic surgery (TORS)All patients underwent primary tumour resection with transoral robotic surgery (TORS) using the daVinci robot (Intuitive Surgical, Sunnyvale CA) | Procedure or surgery | – |
Primary outcome
Local control
Time frame: 2 years after surgery
Proportion of patients without cancer recurrence 2 years after surgery
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 30 Nov 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraglottic Squamous Cell Carcinoma, run by Hospices Civils de Lyon at 1 site 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 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Local control (time frame: 2 years after surgery). 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 30 Nov 2017; AzTrials last refreshed its copy on 30 Oct 2026.