Laryngeal CancerNCT03747783
Nomograms to Precisely Predict Conditional Risk of Survival for Patients With Laryngeal Cancer
An observational study of Laryngeal Cancer, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Advanced laryngeal squamous cell carcinoma (SCC) remains a highly morbid and fatal disease despite aggressive interventions. Mortality is high in this cohort: laryngeal cancer affects over 13 000 patients in the United States, with over 3500 deaths annually.The results of the Veterans Affairs Cooperative Studies… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laryngeal Cancer
- What is being tested?
- Radical Operation
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2013to 3 Mar 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: laryngeal carcinoma patients with radical surgery
Who may be able to join
- laryngeal carcinoma patients with radical surgery
Who cannot join
- multiple primarry malignant neo-plasms
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Genglong Liu
Guangzhou, State..., 510080
Genglong Liu, +8615626405844, lglong3@mail2.sysu.edu.cn
About this study
Official title: Development and Validation of Nomograms to Precisely Predict Conditional Risk of Survival for Patients With Laryngeal Cancer: a Single-institutional Study
Advanced laryngeal squamous cell carcinoma (SCC) remains a highly morbid and fatal disease despite aggressive interventions. Mortality is high in this cohort: laryngeal cancer affects over 13 000 patients in the United States, with over 3500 deaths annually.The results of the Veterans Affairs Cooperative Studies Program Laryngeal Cancer Trial and subsequent studies demonstrated similar overall survival (OS) rates for organ preservation protocols involving radiotherapy (RT) or chemoradiotherapy (CRT) when compared to surgery, with the benefit of preserving the larynx in a large majority of patients. As such, the use of RT or CRT has become the predominant initial intervention for patients with laryngeal SCC.However, the prognosis of recurrent and persistent laryngeal SCC is particularly dire.In this study,the investigators sought to identify preoperative predictors of survival for patients with recurrent or persistent laryngeal SCC in order to set patient expectations and address modifiable risk factors. Identification of predictors of survival may also identify patients who could benefit from novel therapeutic agents in a neo/adjuvant fashion. Herein,we examine a cohort of patients with recurrent or persistent laryngeal SCC after definitive RT/CRT who has undergone total laryngectomy in order to identify potential preoperative predictors of clinical outcomes.
Read the detailed description
Demographic, clinical, and survival data were abstracted. Death was verified via medical records and the social security death index. Primary outcome measures were OS (time from salvage laryngectomy to death from any cause), disease-specific survival (DSS; time from salvage laryngectomy to death from recurrent/persistent laryngeal SCC), and DFS (time from salvage laryngectomy to laryngeal SCC recurrence)
- Conditions
- Laryngeal Cancer
- Being tested
- Radical Operation
- Keywords
- Survival, Nomograms, Laryngeal cancer
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical OperationProcedure or surgery
The surgery treatment selection was based on the American Joint Committee on Cancer stage both of the primary and of the recurrence, as well as on patterns of local spread that were not included in the T classification and on the general condition and preferences of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Survival Group | status from radical operation to follow-up Receives: Procedure: Radical Operation | |
| Non-Survival Group | status from radical operation to follow-up Receives: Procedure: Radical Operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
time from laryngectomy to death from any cause
Measured: Follow up 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start3 Jan 2013
- Primary completion3 Jan 2019 (estimated)
- Study completion3 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GengLong Liu, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xiaojun Tan, Study chair, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747783
- Sponsor's protocol ID
- Laryngeal cacer
- Status last verified
- Nov 2018
- First submitted
- 17 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Nomograms to Precisely Predict Conditional Risk of Survival for Patients With Laryngeal Cancer: a Single-institutional Study
- ClinicalTrials.gov ID
- NCT03747783
- Acronym / sponsor ID
- Laryngeal cacer
- Conditions
- Laryngeal Cancer
- Keywords
- Survival, Nomograms, Laryngeal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 3 Jan 2013 (actual)
- Primary completion
- 3 Jan 2019 (estimated)
- Study completion
- 3 Mar 2019 (estimated)
- First posted
- 20 Nov 2018 (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.
Advanced laryngeal squamous cell carcinoma (SCC) remains a highly morbid and fatal disease despite aggressive interventions. Mortality is high in this cohort: laryngeal cancer affects over 13 000 patients in the United States, with over 3500 deaths annually.The results of the Veterans Affairs Cooperative Studies Program Laryngeal Cancer Trial and subsequent studies demonstrated similar overall survival (OS) rates for organ preservation protocols involving radiotherapy (RT) or chemoradiotherapy (CRT) when compared to surgery, with the benefit of preserving the larynx in a large majority of patients. As such, the use of RT or CRT has become the predominant initial intervention for patients with laryngeal SCC.However, the prognosis of recurrent and persistent laryngeal SCC is particularly dire.In this study,the investigators sought to identify preoperative predictors of survival for patients with recurrent or persistent laryngeal SCC in order to set patient expectations and address modifiable risk factors. Identification of predictors of survival may also identify patients who could benefit from novel therapeutic agents in a neo/adjuvant fashion. Herein,we examine a cohort of patients with recurrent or persistent laryngeal SCC after definitive RT/CRT who has undergone total laryngectomy in order to identify potential preoperative predictors of clinical outcomes.
Detailed description
Demographic, clinical, and survival data were abstracted. Death was verified via medical records and the social security death index. Primary outcome measures were OS (time from salvage laryngectomy to death from any cause), disease-specific survival (DSS; time from salvage laryngectomy to death from recurrent/persistent laryngeal SCC), and DFS (time from salvage laryngectomy to laryngeal SCC recurrence)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survival Group | – | Procedure: Radical Operationstatus from radical operation to follow-up |
| Non-Survival Group | – | Procedure: Radical Operationstatus from radical operation to follow-up |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- laryngeal carcinoma patients with radical surgery
Key inclusion criteria (1 listed)
- laryngeal carcinoma patients with radical surgery
Key exclusion criteria (1 listed)
- multiple primarry malignant neo-plasms
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 |
|---|---|---|
| Radical OperationThe surgery treatment selection was based on the American Joint Committee on Cancer stage both of the primary and of the recurrence, as well as on patterns of local spread that were not included in the T classification and on the general condition and preferences of each patient. | Procedure or surgery | Non-Survival Group, Survival Group |
Primary outcome
Overall survival
Time frame: Follow up 5 year
time from laryngectomy to death from any cause
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Xiaojun Tan study chair
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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 Laryngeal Cancer, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 1 inclusion and 1 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 27 Nov 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Genglong Liu (+8615626405844, lglong3@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Follow up 5 year). 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 27 Nov 2018.