UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003623 |
|---|---|
| Receipt number | R000004390 |
| Scientific Title | A phase II trial of endoscopic submucosal dissection (ESD) for superficial pharyngeal cancer |
| Date of disclosure of the study information | 2010/05/17 |
| Last modified on | 2020/05/25 08:29:24 |
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Basic information
Public title
A phase II trial of endoscopic submucosal dissection (ESD) for superficial pharyngeal cancer
Acronym
A phase II trial of ESD for superficial pharyngeal cancer
Scientific Title
A phase II trial of endoscopic submucosal dissection (ESD) for superficial pharyngeal cancer
Scientific Title:Acronym
A phase II trial of ESD for superficial pharyngeal cancer
Region
| Japan |
Condition
Condition
superficial pharyngeal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of ESD for superficial pharyngeal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete en block resection rate
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic submucosal dissection (ESD)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Superficial pharyngeal carcinoma confined to subepithelial lesion without lymphnode metastasis.
Key exclusion criteria
1)Patients with hematologicalabnormality
2)Active synchronous or metachronous malignancy
3)Patients with severe organ failure
4)Others who were thought to be unsuitable by the investigator.
5)Patients who underwent radiation therapy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Noboru |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Gastrointestinal Oncology
Zip code
537-8511
Address
1-3-3 Nakamichi, Higashinariku, Osaka 537-8511 Japan
TEL
06-6972-1181
hanaoka-no@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Hanaoka |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Gastrointestinal Oncology
Zip code
537-8511
Address
nakamichi higashinari-ku 1-3-3 Osaka, Japan
TEL
06-672-1181
Homepage URL
hanaoka-no@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Address
Nakamichi
Tel
06-6972-1181
mitui-ku@mc.pref.osaka.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
| 2010 | Year | 05 | Month | 17 | 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
| 2010 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
Management information
Registered date
| 2010 | Year | 05 | Month | 17 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004390
