UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039545 |
|---|---|
| Receipt number | R000045002 |
| 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 |
| Date of disclosure of the study information | 2020/02/20 |
| Last modified on | 2020/02/20 13:59:50 |
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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
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
hasegawa.hisashi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045002
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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