UMIN-CTR Clinical Trial

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 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
Email	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
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	Kurume University Hospital
Address	67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
Tel	0942-35-3311
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029852