UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024848
Receipt number R000028491
Scientific Title Analysis of Gene expression to elucidate the cause of endometriosis and endometriosis associated ovarian cancer.
Date of disclosure of the study information 2016/11/16
Last modified on 2016/11/16 09:12:14

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Basic information

Public title

Analysis of Gene expression to elucidate the cause of endometriosis and endometriosis associated ovarian cancer.

Acronym

Analysis of Gene expression to elucidate the cause of endometriosis and endometriosis associated ovarian cancer.

Scientific Title

Analysis of Gene expression to elucidate the cause of endometriosis and endometriosis associated ovarian cancer.

Scientific Title:Acronym

Analysis of Gene expression to elucidate the cause of endometriosis and endometriosis associated ovarian cancer.

Region

Japan


Condition

Condition

Endometriosis assciated ovarian cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To determine the gene controlling the development of endometriosis and endometriosis-associated cancer, we analyze the gene expression in enondometriotic cyst, ascites,blood and cancer using miRNA.

Basic objectives2

Others

Basic objectives -Others

To obtain the necessary genetic information to prospect the malignant transformation of endometriosis.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Making the list of miRNA extracted from enondometriotic cyst, ascites,blood and cancer using miRNA.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Gene

Interventions/Control_1

To determine the target miRNA causing malignant transformation of endometriosi,we will investigate the miRNA expression in 5 each case of endometriosis and endometriosis assciated cancer.

Interventions/Control_2

Following determining the target miRNA,
we will scrutinize the target miRNA expression in total 100cases of endometriosis and endometriosis assciated cancer.

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

The patients who undertake operation of endometriosis or endometriosis associated cancer in Osaka Medical College affiliated hospital.

Key exclusion criteria

The case in which the consensus to join the study is not available.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahide Ohmichi

Organization

Osaka Medical College

Division name

Obstetrics and Gynecology

Zip code


Address

Daigakumachi 2-7, Takatsuki cyty, Osaka, Japan

TEL

072-683-1221

Email

m-ohmichi@osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshito Terai

Organization

Osaka Medical College

Division name

Obstetrics and Gynecology

Zip code


Address

Daigakumachi 2-7, Takatsuki cyty, Osaka, Japan

TEL

072-683-1221

Homepage URL


Email

y-terai@osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College

Organization

Division

Category of Funding Organization

Other

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

2016 Year 11 Month 16 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

Preinitiation

Date of protocol fixation

2016 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 11 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 11 Month 15 Day

Last modified on

2016 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028491


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name