UMIN-CTR Clinical Trial

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
Email	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
Email	higashino-pla@umin.ac.jp

Sponsor
Institute	Oral Pharyngeal Esophageal Operation and Reconstruction Analytical Group (OPERA)
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031595