UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027583 |
|---|---|
| Receipt number | R000031595 |
| Scientific Title | The multicenter prospective observational study for evaluating the rate of dysphagia after tongue reconstruction |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2022/12/05 21:05:10 |
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Basic information
Public title
The multicenter prospective observational study for evaluating the rate of dysphagia after tongue reconstruction
Acronym
The multicenter prospective observational study for tongue reconstruction
Scientific Title
The multicenter prospective observational study for evaluating the rate of dysphagia after tongue reconstruction
Scientific Title:Acronym
The multicenter prospective observational study for tongue reconstruction
Region
| Japan |
Condition
Condition
Tongue cancer
Classification by specialty
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the rate of dysfunction after tongue reconstruction
Basic objectives2
Others
Basic objectives -Others
The rate of dysphagia at twelve months after tongue reconstruction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of dysphagia at twelve months after tongue reconstruction
Key secondary outcomes
The rate of aspiration within twelve months after tongue reconstruction
The rate of postoperative complications within twelve months after tongue reconstruction
Base
Study type
Observational
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Established diagnosis of primary squamous cell carcinoma of tongue.
2) Subtotal or total glossectomy is performed.
3) Tongue reconstruction is performed using free flap transfer.
4) No surgical histories of intraoral reconstruction.
5) Glossectomy is performed without mandibular segmentectomy, or resection of soft palate, or larynx, or skin.
6) No surgical histories for oropharyngeal, or hypopharyngeal, or laryngeal cancer.
7) No surgical histories for esophageal, or gastric cancer.
8) No synchronous advanced cancer histories.
9) No metastases are detected.
10) Radical resection is performed.
11) Age of 20 years, or over 20 years.
12) Written informed consent has been obtained.
Key exclusion criteria
1) ECOG performance status score 2 - 4.
2) Patients with severe condition.
3) Patients who are considered to be ineligible by referring physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Araki |
Organization
Shizuoka Cancer Center Hospital
Division name
Division of Plastic and Reconstructive Surgery
Zip code
411-8777
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
j.araki@scchr.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Higashino |
Organization
National Cancer Center Hospital East
Division name
Department of Plastic and Reconstructive Surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa-shi, Chiba, Japan
TEL
04-7133-1111
Homepage URL
higashino-pla@umin.ac.jp
Sponsor or person
Institute
Oral Pharyngeal Esophageal Operation and Reconstruction Analytical Group (OPERA)
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center Hospital
Address
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
Tel
055-989-5222
tansaku_office@scchr.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
| 2017 | Year | 06 | Month | 01 | 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
188
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
| 2017 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 17 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 12 | Day |
Other
Other related information
Preoperative status
Operative record
Postoperative status at discharge
Assessment of function at six months after tongue reconstruction
Assessment of function at twelve months after tongue reconstruction
Management information
Registered date
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031595
| 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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