UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031287 |
|---|---|
| Receipt number | R000035625 |
| Scientific Title | The efficacy and safety of improved Mohs' paste for gynecological malignancy: multicenter prospective trial |
| Date of disclosure of the study information | 2018/02/14 |
| Last modified on | 2019/08/16 13:17:59 |
* 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 efficacy and safety of improved Mohs' paste for gynecological malignancy: multicenter prospective trial
Acronym
The efficacy and safety of Mohs' paste for gynecological malignancy
Scientific Title
The efficacy and safety of improved Mohs' paste for gynecological malignancy: multicenter prospective trial
Scientific Title:Acronym
The efficacy and safety of Mohs' paste for gynecological malignancy
Region
| Japan |
Condition
Condition
Gynecological malignancy(including metastatic)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technique completion, condition control(hemostasis, foul smell, discharge)
Key secondary outcomes
Survival, pain level, other complication
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
| Medicine | Maneuver |
Interventions/Control_1
Morhs' paste + 10% Zinc oxide single ointment
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
Female
Key inclusion criteria
1) Observance of clinical symptoms due to gynecological malignancy
2) Resistant to anti-cancer agents or difficult to treat
3) Patient consent has been obtained from the patient in writing
Key exclusion criteria
1) Pregnant patients, possibility of pregnancy, postpartum within 28 days, lactating
2) Patients judged by doctor to be unsuitable for study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shintaro Yanazume |
Organization
Kagoshima University Hospital
Division name
Obstetrics & Gynecoogy
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5423
s-yana@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Yanazume |
Organization
Kagoshima University Hospital
Division name
Obstetrics & Gynecoogy
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5423
Homepage URL
s-yana@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
鹿児島大学病院（鹿児島県）
鹿児島市立病院（鹿児島県）
鹿児島医療センター（鹿児島県）
鹿児島市医師会病院（鹿児島県）
済生会川内病院（鹿児島県）
県民健康プラザ鹿屋医療センター（鹿児島県）
県立大島病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2019 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035625
