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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027122
Receipt No. R000031083
Scientific Title A prospective study of the usefulness of liquid biopsy as biomarker during diagnosis and treatment for the endometrial cancer
Date of disclosure of the study information 2017/05/08
Last modified on 2019/04/29

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Basic information
Public title A prospective study of the usefulness of liquid biopsy as biomarker during diagnosis and treatment for the endometrial cancer
Acronym A prospective study of the usefulness of liquid biopsy as biomarker for the endometrial cancer
Scientific Title A prospective study of the usefulness of liquid biopsy as biomarker during diagnosis and treatment for the endometrial cancer
Scientific Title:Acronym A prospective study of the usefulness of liquid biopsy as biomarker for the endometrial cancer
Region
Japan

Condition
Condition endometrial cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to determine the usefulness of liquid biopsy as biomarker for endometrial cancer by concordance rate of liquid biopsy and gene mutation in tumor tissue specimen.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Concordance rate of liquid biopsy and gene mutation in tumor tissue specimen
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Female
Key inclusion criteria The patients with endometrial cancer who are planned to treat according our protocol.
Key exclusion criteria The patients are followed our protocol.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kazuhiko
Middle name
Last name Ino
Organization Wakayama medical university
Division name Obstetrics and gynecology
Zip code 641-0012
Address 811-1 Kimiidera Wakayama, Japan
TEL 0734410631
Email kazuino@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Naoyuki
Middle name
Last name Iwahashi
Organization Wakayama Medical University
Division name Obstetrics and gynecology
Zip code 641-0012
Address 811-1 Kimiidera Wakayama, Japan
TEL 0734410631
Homepage URL
Email naoyuki@wakayama-med.ac.jp

Sponsor
Institute Wakayama medical university
Institute
Department

Funding Source
Organization research expense
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Genome Biology, Kindai University Faculty of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Obstetrics and Gynecology, Wakayama Medical University
Address 811-1 Kimiidera, Wakayama, Japan
Tel 073-441-0631
Email naoyuki@wakayama-med.ac.jp

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 和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 08 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 04 Month 21 Day
Date of IRB
2017 Year 05 Month 08 Day
Anticipated trial start date
2017 Year 05 Month 08 Day
Last follow-up date
2022 Year 05 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observing

Management information
Registered date
2017 Year 04 Month 25 Day
Last modified on
2019 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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