UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023418 |
|---|---|
| Receipt number | 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 23:39:43 |
* 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 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 | Obstetrics 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
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
m.d.tsukuru@gmail.com
Sponsor or person
Institute
Research Hospital, The Institute of Medical Science, The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026842
