UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study on the effect of resection, laser treatment, and risk factors for malignant transformation and postoperative recurrence in vocal fold leukoplakia
Acronym	A retrospective study on the effect of resection, laser treatment, and risk factors for malignant transformation and postoperative recurrence in vocal fold leukoplakia
Scientific Title	A retrospective study on the effect of resection, laser treatment, and risk factors for malignant transformation and postoperative recurrence in vocal fold leukoplakia
Scientific Title:Acronym	A retrospective study on the effect of resection, laser treatment, and risk factors for malignant transformation and postoperative recurrence in vocal fold leukoplakia
Region	Japan

Condition
Condition	Vocal fold leukoplakia
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compare the clinical characteristics of patients with vocal fold leukoplakia who have visited our hospital with those who have not recurred and clarify the differences. In addition, the objective was to reduce the burden on patients to formulate a treatment policy, take countermeasures, and reduce recurrent cases.
Basic objectives2	Others
Basic objectives -Others	Vocal fold leukoplakia is a benign disease caused by hoarseness, caused by the thickening of the squamous epithelium. The causes include various stages from temporary hyperplasia associated with inflammation such as the common cold to dysplasia involving infiltration of atypical cells into the epithelium and cancer. It is known that even if hyperplasia is found in pathological diagnosis by tissue biopsy, malignant transformation occurs only by follow-up observation. Extensive resection for complete removal of lesions impairs speech function. In addition, the canceration of recurrent lesions is still being reported. If this study reduces the rate of recurrence of vocal fold leukoplakia, it can prevent cancer associated with the recurrence and reduce the psychological, physical, and economic burden on patients associated with treatment for the recurrence.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The postoperative recurrence rate of vocal fold leukoplakia
Key secondary outcomes	Gender, age, drinking history, smoking history, pathological diagnosis, pharyngolaryngeal reflux, unilateral or bilateral vocal cord lesions, lesion length relative to the total length of the vocal cords, postoperative follow-up period, presence or absence of inferior surface lesions, associative lesions Presence/absence of laryngeal expansion

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Those that meet all of the following criteria Vocal cord leukoplakia Age: 20 years old or older, less than 90 years old Gender: both gender They were the first to undergo surgery for the above disease at Nihon University Hospital. Surgery involves both tissue sampling and resection of the lesion and Ho; YAG laser treatment
Key exclusion criteria	Diagnosis of pathological carcinoma in situ and invasive carcinoma and those who have previous treatment
Target sample size	39

Research contact person
Name of lead principal investigator	1st name Hisashi Middle name Last name Hasegawa
Organization	Nihon University Hospital
Division name	Otorhinolaryngology and Head and Neck Surgery
Zip code	101-8309
Address	1-6, Kandasurugadai
TEL	0332931711
Email	hasegawa.hisashi@nihon-u.ac.jp

Public contact
Name of contact person	1st name Hisashi Middle name Hasegawa Last name Hasegawa
Organization	Nihon University Hospital
Division name	Otorhinolaryngology and Head and Neck Surgery
Zip code	101-8309
Address	1-6, Kandasurugadai
TEL	0332931711
Homepage URL
Email	hasegawa.hisashi@nihon-u.ac.jp

Sponsor
Institute	Nihon University Hospital
Institute
Department

Funding Source
Organization	Nihon University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Otorhinolaryngology and Head and Neck Surgery
Address	1-6, Kandasurugadai
Tel	03-3293-1711
Email	hasegawa.hisashi@nihon-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	39
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 08 Month 01 Day
Date of IRB	2019 Year 09 Month 16 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A retrospective review

Management information
Registered date	2020 Year 02 Month 20 Day
Last modified on	2020 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045002