UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030553
Receipt number 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 2023/06/30 14:51:19

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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

Obstetrics 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 or person

Institute

Kansai Clinical Oncology Group (KCOG)

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2017 Year 06 Month 24 Day

Date of IRB

2017 Year 06 Month 24 Day

Anticipated trial start date

2017 Year 08 Month 14 Day

Last follow-up date

2020 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, 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

2023 Year 06 Month 30 Day



Link to view the page

Value
https://center6.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