UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027583
Receipt No. 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 2017/12/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last name of lead principal investigator
1st name
Middle name
Last name Masahiro Nakagawa
Organization Shizuoka Cancer Center Hospital
Division name Division of Plastic and Reconstructive Surgery
Zip code
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
TEL 055-989-5222
Email m.nakagawa@scchr.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takuya Higashino
Organization National Cancer Center Hospital East
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba, 277-8577, 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
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2017 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031595

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.