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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027294
Receipt No. R000031276
Scientific Title Cancer related gene alteration analysis study in patients with endometrial cancer
Date of disclosure of the study information 2017/05/10
Last modified on 2019/08/07

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Basic information
Public title Cancer related gene alteration analysis study in patients with endometrial cancer
Acronym Cancer related gene alteration analysis study in patients with endometrial cancer (ECGA STUDY)
Scientific Title Cancer related gene alteration analysis study in patients with endometrial cancer
Scientific Title:Acronym Cancer related gene alteration analysis study in patients with endometrial cancer (ECGA STUDY)
Region
Japan

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

Objectives
Narrative objectives1 1) To elucidate frequency of gene alteration in patient with endometrial cancer using blood and surgically resected tumor tissues.
2) To explore the utility of biomarkers, comparing the result of gene alteration with clinical data which are collected from this study.
Basic objectives2 Others
Basic objectives -Others frequency of gene alteration
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes [Blood]
Gene mutation and chromosome copy number abnormality analysis using the Droplet Digital PCR.
PIK3CA gene mutation, AKT1 gene mutation and amplification, AKT2 gene amplification.
[FFPE tumor tissue]
Analysis using Droplet Digital PCR and PCR.
PIK3CA gene mutation, AKT1 gene mutation and amplification, AKT2 gene amplification.
Key secondary outcomes [FFPE tumor tissue]
Gene analysis using NGS
Target gene will be updated in the future depending on the contents of the chip.

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

Not applicable
Gender Female
Key inclusion criteria 1) Patients who are diagnosed as the advanced recurrent endometrial cancer by surgery or by histologically or cytological biopsy and there is no standard chemotherapy choices (not be responsive to the existing chemotherapy).
2) Female patients over 20 years old at the time of written informed consent.
3) Patients who agreed on the informed consent including document offer in the study.
4) The patient capable of providing a blood and tumor tissue samples which is collected and stored at the time of diagnosis or surgery.
Key exclusion criteria 1) Patients judged by their physician to be unfit to participate in this study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Mikio
Middle name
Last name Mikami
Organization Tokai University
Division name Department of Obstetrics and Gynecology, School of Medicine
Zip code 259-1193
Address 143 Shimokasuya, Isehara-shi, Kanagawa
TEL 0463-93-1121
Email mmikami@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Ichiyanagi
Organization SRL Medisearch Inc.
Division name Clinical Research Development ECGA STUDY secretariat
Zip code 1631310
Address Shinjuku I-Land-Tower 10F,6-5-1 Nishishinjuku,Shijuku-ku,Tokyo
TEL 03-6692-0499
Homepage URL
Email sme.ecga-study@miraca.com

Sponsor
Institute SRL Medisearch Inc.
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Clinical Research, Tokai University
Address 143 Shimogiya, Isehara City, Kanagawa
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.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 東海大学医学部付属病院(神奈川県)、東京大学医学部附属病院(東京都)、千葉大学医学部附属病院(千葉県)、静岡県立静岡がんセンター(静岡県)、自治医科大学附属病院(栃木県)、杏林大学医学部付属病院(東京都)、聖マリアンナ医科大学病院(神奈川県),千葉県がんセンター(千葉県)、愛知県がんセンター中央病院(愛知県)、国立病院機構東京医療センター(東京都)、東北大学病院(宮城県)、筑波大学附属病院(茨城県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 10 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 02 Month 07 Day
Date of IRB
2017 Year 03 Month 18 Day
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation items are as follows.
[Blood]
Gene mutation and chromosome copy number abnormality analysis using the Droplet Digital PCR
PIK3CA gene mutation, AKT1 gene mutation and amplification, AKT2 gene amplification
[FFPE tumor tissue]
1)Analysis using Droplet Digital PCR and PCR
PIK3CA gene mutation, AKT1 gene mutation and amplification, AKT2 gene amplification
2)Gene analysis using NGS

Management information
Registered date
2017 Year 05 Month 10 Day
Last modified on
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031276

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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