UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025968 |
|---|---|
| Receipt number | R000029852 |
| Scientific Title | Survey of vulvovaginal melanoma in Japan |
| Date of disclosure of the study information | 2017/02/02 |
| Last modified on | 2020/08/08 20:58:30 |
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Basic information
Public title
Survey of vulvovaginal melanoma in Japan
Acronym
JGOG1078S
Scientific Title
Survey of vulvovaginal melanoma in Japan
Scientific Title:Acronym
JGOG1078S
Region
| Japan |
Condition
Condition
vulvovaginal melanoma
Classification by specialty
| Obstetrics and Gynecology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To conduct a survey of vulvovaginal melanoma in Japan to clarify patient characteristics and the current status of treatment regimens and thereby obtain useful information for planning future prospective clinical studies of vulvovaginal melanoma
Basic objectives2
Others
Basic objectives -Others
Retrospective observational study
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To conduct a survey of vulvovaginal melanoma in Japan to clarify patient characteristics and the current status of treatment regimens and thereby obtain useful information for planning future prospective clinical studies of vulvovaginal melanoma
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Patients who received treatment for vulvar cancer during the 21-year period from January 1995 through December 2015, including those who initially received palliative therapy
(2) Primary vulvovaginal melanoma, not including metastatic vulvovaginal melanoma
Key exclusion criteria
metastatic vulvovaginal melanoma
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Nishio |
Organization
Kurume University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7573
shinshin@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Nishio |
Organization
Kurume University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7573
Homepage URL
shinshin@med.kurume-u.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group (JGOG)
Japanese Skin Cancer Society (JSCS)
Institute
Department
Personal name
Funding Source
Organization
Japanese Gynecologic Oncology Group (JGOG)
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
Kurume University Hospital
Address
67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
Tel
0942-35-3311
sangaku@kurume-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 02 | 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 | 11 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 01 | Day |
Other
Other related information
Methods
The survey variables described in Study variables will be entered into Excel worksheets. Excel files will be sent as disks by mail. After data entry, the completed survey questionnaires will be returned to the Study Secretariat by means of self-addressed envelopes.
Survey variables
a. Patient characteristics
Age, site, Breslow thickness, TNM substage, ulceration, mitotic rate, microsatellite, depth, melanoma subtype, AJCC stage, initial treatment, date of starting treatment, date of completing treatment, presence or absence of recurrence, date of confirming recurrence, treatment for recurrence, survival status, final date of confirming survival
b. Surgical therapy
Vulva or vagina: Extensive total vulvectomy or vaginectomy, radical partial vulvectomy or vaginectomy, sentinel lymph-node dissection
c. Radiotherapy
Preoperative, initial, and postoperative radiotherapy: Radiotherapy alone (radiation fields, radiation methods [curative radiation and palliative radiation], Linac, electron beams, total radiation dose, treatment duration, completion rate)
Preoperative, initial, and postoperative chemoradiotherapy: (Radiation fields, radiation methods, Linac, electron beams, total radiation dose, treatment duration, regimen, number of courses, completion rate), adverse events (including late toxicity)
d. Chemotherapy
Preoperative, initial, and postoperative chemotherapy: regimens, number of courses, adverse events
Number of patients and study period
In a retrospective study conducted by Kurume University Hospital, data on about 5 patients during a 15-year period. The mean number of patients in JGOG institutions is estimated to be about 2. The total number of patients at the 200 institutions is therefore projected to be 400. Given the collection rate in the present study, the target number of patients is set at 200, equivalent to half of the 400 patients.
Management information
Registered date
| 2017 | Year | 02 | Month | 02 | Day |
Last modified on
| 2020 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029852
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
