UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023449 |
|---|---|
| Receipt number | R000026884 |
| Scientific Title | The prospective study on the safety of metalic markers for radiotherapy of gynecological cancer |
| Date of disclosure of the study information | 2016/08/04 |
| Last modified on | 2019/11/01 16:20:31 |
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Basic information
Public title
The prospective study on the safety of metalic markers for radiotherapy of gynecological cancer
Acronym
The safety of metal markers for radiotherapy of gynecological cancer
Scientific Title
The prospective study on the safety of metalic markers for radiotherapy of gynecological cancer
Scientific Title:Acronym
The safety of metal markers for radiotherapy of gynecological cancer
Region
| Japan |
Condition
Condition
Cervical cancer, Endometrial cancer, Vaginal cancer, Vulvar cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
No metalic fiducial markers covered by insurance exist in Japan. In other institutions in Japan, handmade titanium markers, or gold markers which were approved by insurance for other carcinomas were often used. The purpose was to investigate the safety of metalic markers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sever complications within 3 months after the implantation of metalic markers.
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
Implantation of metalic markers into tumors or the tissue close to tumors
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
Cervical cancer, Uterine endometrial cancer, Vaginal cancer, Vulvar cancer;
PS 0-2;
benefit of marker implantation
Written informed consent.
Key exclusion criteria
Coagulation disorder;
Severe coexisting disease;
Pregnancy, possible pregnancy.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SHUHEI SEKII |
Organization
Hyogo Cancer Center
Division name
Department of Radiation Oncology
Zip code
Address
70, Kitaoji-cho 13, Akashi-shi, Hyogo, Japan
TEL
078-929-1151
ssekii@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SHUHEI SEKII |
Organization
Hyogo Cancer Center
Division name
Department of Radiation Oncology
Zip code
Address
70, Kitaoji-cho 13, Akashi-shi, Hyogo, Japan
TEL
078-929-1151
Homepage URL
ssekii@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
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
兵庫がんセンター/Hyogo Cancer Center
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 04 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
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 | 02 | Day |
Last modified on
| 2019 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026884
