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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040181
Receipt No. R000045810
Scientific Title An integrated multi-omics study of tumor heterogeneity in patients with treatment-resistant malignant cancer
Date of disclosure of the study information 2020/04/16
Last modified on 2020/10/30

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Basic information
Public title An integrated multi-omics study of tumor heterogeneity in patients with treatment-resistant malignant cancer
Acronym A study of tumor heterogeneity in patients with treatment-resistant malignant cancer
Scientific Title An integrated multi-omics study of tumor heterogeneity in patients with treatment-resistant malignant cancer
Scientific Title:Acronym A study of tumor heterogeneity in patients with treatment-resistant malignant cancer
Region
Japan

Condition
Condition malignant cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To reveal the molecular heterogeneity in patients with treatment-resistant malignant cancer
Basic objectives2 Others
Basic objectives -Others Identification of biomarkers predicting therapeutic resistance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Gene alterations by DNA sequence
2. Gene expression and fusion genes by tarRNA sequence
3. Epigenomic alterations by micro-array
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who agree with the content of this study and submit the written consent form
Key exclusion criteria Other than those above
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Jumpei
Middle name
Last name Takeshita
Organization Kansai Electric Power Hospital
Division name Department of Oncology
Zip code 553-0003
Address 2-1-7Fukushima,Fukushima-ku,Osaka
TEL 0664585821
Email takeshita.jumpei@e4.kepco.co.jp

Public contact
Name of contact person
1st name Jumpei
Middle name
Last name Takeshita
Organization Kansai Electric Power Hospital
Division name Department of Oncology
Zip code 553-0003
Address 2-1-7Fukushima,Fukushima-ku,Osaka
TEL 0664585821
Homepage URL
Email takeshita.jumpei@e4.kepco.co.jp

Sponsor
Institute Kansai Electric Power Hospital
Institute
Department

Funding Source
Organization Kansai Electric Power Hospital
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 Kansai Electric Power Hospital
Address 2-1-7Fukushima,Fukushima-ku,Osaka
Tel 0664585821
Email koga.kazuhiro@c3.kepco.co.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

Other administrative information
Date of disclosure of the study information
2020 Year 04 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 Enrolling by invitation
Date of protocol fixation
2020 Year 04 Month 10 Day
Date of IRB
2020 Year 04 Month 10 Day
Anticipated trial start date
2020 Year 04 Month 16 Day
Last follow-up date
2025 Year 04 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2020 Year 04 Month 16 Day
Last modified on
2020 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045810

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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