UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005467 |
|---|---|
| Receipt number | R000006415 |
| Scientific Title | Retrospective study for long-term outcome of trans-oral organ-preserving pharyngeal endoscopic resection for superficial pharyngeal cancer |
| Date of disclosure of the study information | 2011/04/19 |
| Last modified on | 2013/05/30 22:57:42 |
* 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
Retrospective study for long-term outcome of trans-oral organ-preserving pharyngeal endoscopic resection for superficial pharyngeal cancer
Acronym
H&N cancer ESD/EMR study
Scientific Title
Retrospective study for long-term outcome of trans-oral organ-preserving pharyngeal endoscopic resection for superficial pharyngeal cancer
Scientific Title:Acronym
H&N cancer ESD/EMR study
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy for torans-oral pharyngeal endoscopic resection (TOPER) for superficial cancer in the head and neck cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
cause-specific survival, complete resection rate, safety
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
superficial head and neck cancer treated by TOPER
Key exclusion criteria
salvage treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
54 Kawahara cho, Shogoin, Sakyo, Kyoto
TEL
075-751-4592
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
mmuto@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 08 | Month | 31 | Day |
Other
Other related information
to analysis of clinical and pathological data
Management information
Registered date
| 2011 | Year | 04 | Month | 19 | Day |
Last modified on
| 2013 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006415
