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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023418
Receipt No. R000026842
Scientific Title The Safety of Mohs Paste For Bleedings from Malignant Wound A Phase I Study
Date of disclosure of the study information 2016/08/01
Last modified on 2018/08/22

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Basic information
Public title The Safety of Mohs Paste For Bleedings
from Malignant Wound
A Phase I Study
Acronym BMW study
Scientific Title The Safety of Mohs Paste For Bleedings
from Malignant Wound
A Phase I Study
Scientific Title:Acronym BMW study
Region
Japan

Condition
Condition malignant wound
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Hematology and clinical oncology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Breast surgery Obsterics and gynecology Dermatology
Oto-rhino-laryngology Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimete the duration limiting toxicity and the maximum tolerated duration of Mohs paste application for bleeding from malignant wound
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes the duration limiting toxicity of Mohs paste application for bleeding from malignant wound
Key secondary outcomes the incidence of adverse events
the rate of achieving hemostasis
the duration of hemostasis
the change of QOL of the patients

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Mohs paste will be applied for 30 minutes, 1 hour, 2 hours, or 4 hours.
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)Patients who were diagnosed as a solid carcinoma pathologically or clinically.
2)Patients who are suffering from bleeding from malignant wound.
3)Patients who are able to be hospitalized.
4)Patients who had a surgery, a radiation therapy, or a chemotherapy (except hormone therapies) over 2 weeks ago.
5)Patients whose life expectancy is estimated more than 4 weeks.
6)Voluntarily signed the written consent form.
Key exclusion criteria 1)Patients who have uncontrolled or active infection except the target malignant wound.
2)Patients who have allergy to zinc or fradiomycin sulfate.
3)Patients who have applied Mohs paste the same target lesion.
4)Patients who have applied the paste that dose not aim to prevent from protecting surface of malignant wound.
5)Patients who are used anticoagulation drug or antithrombocyte drug.
6)Patients whose malignant wound locates near body cavities or large blood vessels.
7)Patients who may be difficult to
keep their safe or to evaluate this study.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroto Ishiki
Organization Research Hospital, The Institute of Medical Science, The University of Tokyo
Division name Department of Palliative Medicine
Zip code
Address 4-6-1, Shirokanedai, Minato-ku, Tokyo
TEL 03-3443-8111
Email ishiki-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsukuru Chiba
Organization Research Hospital, The Institute of Medical Science, The University of Tokyo
Division name Department of Palliative Medicine
Zip code
Address 4-6-1, Shirokanedai, Minato-ku, Tokyo
TEL 03-3443-8111
Homepage URL
Email m.d.tsukuru@gmail.com

Sponsor
Institute Research Hospital, The Institute of Medical Science, The University of Tokyo
Institute
Department

Funding Source
Organization Japanese Society for Palliative Medicine
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
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 東京大学医科学研究所附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 01 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
2016 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 08 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
2016 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026842

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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