UMIN-CTR Clinical Trial

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	Main results already published
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	2019 Year 03 Month 31 Day
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	2022 Year 03 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031276