UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030553
Receipt No. R000034878
Scientific Title Current Status of Primary Malignant Melanoma of Uterus and Ovary in Japan, Retrospective Analysis (KCOG-G1701s)
Date of disclosure of the study information 2017/12/25
Last modified on 2017/12/25

* 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 Current Status of Primary Malignant Melanoma of Uterus and Ovary in Japan, Retrospective Analysis (KCOG-G1701s)
Acronym KCOG-G1701s
Scientific Title Current Status of Primary Malignant Melanoma of Uterus and Ovary in Japan, Retrospective Analysis (KCOG-G1701s)
Scientific Title:Acronym KCOG-G1701s
Region
Japan

Condition
Condition Primary Malignant Melanoma of Uterus and Ovary
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarfy the prognostic factor in primary malignant melanoma of uterus and ovary, we examine the clinicopathological findings and PD-L1 immunohistological expressions.
Basic objectives2 Others
Basic objectives -Others Retrospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prognostic Factors in primary malignant melanoma of uterus and ovary
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 Patients who received treatment for primary uterine and ovarian malignant melanoma during the 20-year period from April 1997 through March 2017
Key exclusion criteria Metastatic uterine and ovarian malignant melanoma
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsutake Yano
Organization Saitama Medical University International Medical Center
Division name Department of Pathology
Zip code
Address 1397-1 Yamane, Hidaka, Saitama 350-1298, Japan
TEL 042-984-0609
Email yano1210@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsutake Yano
Organization Saitama Medical University International Medical Center
Division name Department of Pathology
Zip code
Address 1397-1 Yamane, Hidaka, Saitama 350-1298, Japan
TEL 042-984-0609
Homepage URL
Email yano1210@oita-u.ac.jp

Sponsor
Institute Kansai Clinical Oncology Group (KCOG)
Institute
Department

Funding Source
Organization Kansai Clinical Oncology Group (KCOG)
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 12 Month 25 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
2017 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 14 Day
Last follow-up date
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, body height, body weight, pregnancy and delivery history, past medical history, family medical history, tumor markers, site, Breslow thickness, TNM substage, 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
Uterus and ovary: Simple total hysterectomy, extensive total hysterectomy, radical hysterectomy, salpingo-oophorectomy, tumor resection, lymph-node dissection
c. Radiotherapy
Preoperative, initial, and postoperative radiotherapy: Radiotherapy alone (radiation fields, radiation methods [curative radiation and palliative radiation], total radiation dose, treatment duration, completion rate)
Preoperative, initial, and postoperative chemoradiotherapy: (Radiation fields, radiation methods, total radiation dose, treatment duration, regimen, number of courses, completion rate)
d. Chemotherapy
Preoperative, initial, and postoperative chemotherapy: regimens, number of courses

Management information
Registered date
2017 Year 12 Month 25 Day
Last modified on
2017 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034878

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.