UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024848
Receipt No. 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

* 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 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
Obsterics 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
Institute Osaka Medical College
Institute
Department

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
URL(English) https://upload.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


Contact us.