UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027294 |
|---|---|
| Receipt number | 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 | 2022/03/04 09:32:20 |
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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
| Obstetrics 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
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
sme.ecga-study@miraca.com
Sponsor or person
Institute
SRL Medisearch Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031276
