UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029460 |
|---|---|
| Receipt number | R000033659 |
| Scientific Title | Evaluation of swallowing function after reconstruction surgery for oral,orophayrngeal, and hypopharyngeal cancer using 320-Detector-Row Multislice CT. |
| Date of disclosure of the study information | 2017/10/31 |
| Last modified on | 2021/01/26 08:06:25 |
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Basic information
Public title
Evaluation of swallowing function after reconstruction surgery for oral,orophayrngeal, and hypopharyngeal cancer using 320-Detector-Row Multislice CT.
Acronym
Evaluation of swallowing function after surgery for oral,orophayrngeal, and hypopharyngeal cancer using multislice CT.
Scientific Title
Evaluation of swallowing function after reconstruction surgery for oral,orophayrngeal, and hypopharyngeal cancer using 320-Detector-Row Multislice CT.
Scientific Title:Acronym
Evaluation of swallowing function after surgery for oral,orophayrngeal, and hypopharyngeal cancer using multislice CT.
Region
| Japan |
Condition
Condition
orophayrngeal cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the swallowing movement of the patient who received reconstruction surgery for oropharyngeal cancer using multislice CT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Movement of pharyngeal wall and hyoid bone, larynx during swallow.
Key secondary outcomes
Pharyngeal constriction ratio, Bolus residual ratio, Oral-pharyngeal transit time, MTF score, %LE, Swallowing pressure of pharynx, AsR score,
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Administer multislice CT at frequent checkup, once per person
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) squamous cell carcinoma in head and neck region
(2) primary site is oropharynx
(3) received reconstruction surgery for oropahryngeal cancer between April 1, 2000 and March 31, 2016 at Nagoya university hospital.
(4) not received Radiation therapy before or after surgery
(5) available for clinical records
(6) not received Radiation therapy for another head and neck cancer
(7) not received radiation therapy for other cancer
(8) not have simultaneous or metachronous head and neck cancer
Key exclusion criteria
(1) minority
(2) have systemic infection
(3) have simultaneous or metachronous head and neck cancer
(4) fever over 38 degree
(5) pregnant
(6) have mental disease, and can not decision making
(7) have heart disease that not cured or during treatment
(8) reject to using clinical records
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | takashi |
| Middle name | |
| Last name | maruo |
Organization
Nagoya university
Division name
Otorhinolaryngology
Zip code
4668560
Address
Tsurumai tyou 65, shouwa ward, nagoya city, aichi prefecture, japan
TEL
052-744-2323
yasushif@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | takashi |
| Middle name | |
| Last name | maruo |
Organization
Nagoya university hospital
Division name
Otorhinolaryngology
Zip code
466-8560
Address
Tsurumai tyou 65, shouwa ward, nagoya city, aichi prefecture, japan
TEL
052-744-2323
Homepage URL
tmaruo@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya university hospital
Address
Tsurumai tyou 65, shouwa ward, nagoya city, aichi prefecture, japan
Tel
052-744-2323
tmaruo@med.nagoya-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
| 2017 | Year | 10 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 06 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033659
