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 | 2024/06/06 14:01:00 |
* 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
| 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
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
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
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028491
