UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017080
Receipt No. R000019814
Scientific Title Survey of vulvar cancer in Japan
Date of disclosure of the study information 2015/04/08
Last modified on 2017/10/09

* 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 Survey of vulvar cancer in Japan
Acronym JGOG1075S
Scientific Title Survey of vulvar cancer in Japan
Scientific Title:Acronym JGOG1075S
Region
Japan

Condition
Condition Vulva Cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To conduct a survey of vulvar cancer 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 vulvar cancer
Basic objectives2 Others
Basic objectives -Others Retrospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To conduct a survey of vulvar cancer 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 vulvar cancer
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 10-year period from January 2001 through December 2010, including those who initially received palliative therapy
(2) Primary vulvar cancer, not including metastatic vulvar cancer
(3) All histologic types other than malignant melanoma
Key exclusion criteria Malignant melanoma
Target sample size 1000

Research contact person
Last 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
1st name of contact person
1st name
Middle name
Last name Shin Nishio
Organization Kurume University School of Medicineurume 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)
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
2015 Year 04 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2014 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2017 Year 11 Month 10 Day
Date of closure to data entry
2017 Year 11 Month 17 Day
Date trial data considered complete
2017 Year 12 Month 01 Day
Date analysis concluded
2018 Year 01 Month 31 Day

Other
Other related information 1. 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.

2. Survey variables
a. Patient characteristics
Age, history of pregnancy and delivery, disease stage (FIGO2008), HPV high-risk tests, HPV typing tests, histologic type, tumor diameter, 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: Extensive total vulvectomy, radical partial vulvectomy, sentinel lymph-node dissection
Inguinal region: Unilateral, bilateral shallow inguinal lymph-node dissection, shallow/deep inguinal lymph-node dissection, en bloc method, and separate incision method
Reconstruction: Partial skin grafting, cutaneous flap, and myocutaneous flap
Complications: Evaluation of the incidences and grades of wound dehiscence, edema, infectious lymphangitis, thrombosis, and urinary-tract infection
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

3. Number of patients and study period

Survey period: from August 1, 2014 through March 31, 2015
Target number of patients: 1000

Management information
Registered date
2015 Year 04 Month 08 Day
Last modified on
2017 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019814

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.