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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025968
Receipt No. R000029852
Scientific Title Survey of vulvovaginal melanoma in Japan
Date of disclosure of the study information 2017/02/02
Last modified on 2019/08/07

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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
Obsterics 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
Middle name
Last name Shin Nishio
Organization Kurume University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7573
Email shinshin@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin Nishio
Organization Kurume University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7573
Homepage URL
Email shinshin@med.kurume-u.ac.jp

Sponsor
Institute Japanese Gynecologic Oncology Group (JGOG)
Japanese Skin Cancer Society (JSCS)
Institute
Department

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
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

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 Open public recruiting
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
Date trial data considered complete
Date analysis concluded

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
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029852

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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