UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017080 |
|---|---|
| Receipt number | R000019814 |
| Scientific Title | Survey of vulvar cancer in Japan |
| Date of disclosure of the study information | 2015/04/08 |
| Last modified on | 2020/02/05 13:52:40 |
* 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
| Obstetrics 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
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 Medicineurume 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)
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 Univeristy
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
| 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 12 | Day |
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
| 2020 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.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 |
