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Trial record 10 of 31 for:    Recruiting, Not yet recruiting, Available Studies | "Laryngeal Neoplasms"

Nomograms to Precisely Predict Conditional Risk of Recurrence for Patients With Laryngeal Cancer

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ClinicalTrials.gov Identifier: NCT03595410
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
GengLong Liu, First Affiliated Hospital, Sun Yat-Sen University

Brief 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 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.6 However, the prognosis of recurrent and persistent laryngeal SCC is particularly dire.In this study, we 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.

Condition or disease Intervention/treatment
Recurrent Laryngeal Cancer Other: Recurrence laryngeal cancer

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)

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development and Validation of Nomograms to Precisely Predict Conditional Risk of Recurrence for Patients With Laryngeal Cancer: a Single-institutional Study
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Recurrence laryngeal cancer Other: Recurrence laryngeal cancer
Recurrence laryngeal cancer has a wide range of invasion, rapid progression and poor prognosis.

No recurrence laryngeal cancer Other: Recurrence laryngeal cancer
Recurrence laryngeal cancer has a wide range of invasion, rapid progression and poor prognosis.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Follow up 5 years ]
    time from salvage laryngectomy to death from any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
patients with laryngeal cancer
Criteria

Inclusion Criteria:

patients with a diagnosis of laryngeal squamous cell carcinoma

Exclusion Criteria:

multiple primarry malignant neo-plasms


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595410


Contacts
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Contact: Genglong Liu, MD +8615626405844 lglong3@mail2.sysu.edu.cn

Locations
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China, Guangdong
Genglong Liu Recruiting
Guangzhou, Guangdong, China
Contact: Genglong Liu, MD    +8615626405844    lglong3@mail2.sysu.edu.cn   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Genglong Liu First Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: GengLong Liu, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03595410     History of Changes
Other Study ID Numbers: Laryngeal carcinoma
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by GengLong Liu, First Affiliated Hospital, Sun Yat-Sen University:
risk of recurrence
Nomograms
Laryngeal cancer

Additional relevant MeSH terms:
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Laryngeal Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases