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

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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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name