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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043637
Receipt No. R000049833
Scientific Title Suitable Classification Consortium for Esophageal Squamous Cell Carcinoma Subtype Ad hoc research -Integrated Analysis of previous research and SUCCESS study
Date of disclosure of the study information 2021/03/16
Last modified on 2021/03/16

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Basic information
Public title Suitable Classification Consortium for Esophageal Squamous Cell Carcinoma Subtype
Ad hoc research -Integrated analysis of previous research and SUCCESS study
Acronym SUCCESS Study Ad hoc Research - Integrated Analysis of previous research and SUCCESS study
Scientific Title Suitable Classification Consortium for Esophageal Squamous Cell Carcinoma Subtype
Ad hoc research -Integrated Analysis of previous research and SUCCESS study
Scientific Title:Acronym SUCCESS Study Ad hoc research - Integrated Analysis of previous research and SUCCESS study
Region
Japan

Condition
Condition Esophageal Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To establish a biomarker for highly curative precision medicine in esophageal cancer
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between the subtype classification in esophageal cancer and the therapeutic effect or prognosis of chemoradiotherapy and surgical treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the relationship between the therapeutic effect/prognosis and the subtype classification using the RNA expression pattern of esophageal cancer 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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who participated in the previous study ([Expression profiling of clinical stage II/III esophageal squamous cell carcinoma patients treated with definitive chemoradiotherapy: National Cancer Center Japan IRB 16-97, UMIN-C000000459], and [long-term prognosis of its study: National Cancer Center Japan IRB 19-14]), and SUCCESS Study (Suitable Classification Consortium for Esophageal Squamous Cell Carcinoma Subtype: UMIN000016141)
Key exclusion criteria Patients who disagree with the use of clinical data in this study
Target sample size 375

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Muto
Organization Kyoto University Hospital
Division name Department of Clinical Oncology
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4592
Email mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Shinya
Middle name
Last name Ohashi
Organization Kyoto University Hospital
Division name Preemptive Medicine and Lifestyle Disease Research Center
Zip code 606-8397
Address 53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-754-0073
Homepage URL
Email ohashish@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.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 京都大学医学部附属病院(京都府)、国立がん研究センター研究所(東京都)、近畿大学病院(大阪府)、川崎医科大学総合医療センター(岡山県)、大阪国際がんセンター(大阪府)、長崎大学病院(長崎県)、国立がん研究センター東病院(千葉県)、北里大学病院(神奈川県)、富山大学附属病院(富山県)、千葉県がんセンター(千葉県)、石川県立中央病院(石川県)

Other administrative information
Date of disclosure of the study information
2021 Year 03 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 375
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 No longer recruiting
Date of protocol fixation
2019 Year 10 Month 02 Day
Date of IRB
2020 Year 01 Month 08 Day
Anticipated trial start date
2020 Year 01 Month 08 Day
Last follow-up date
2025 Year 01 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter retrospective observational study

Management information
Registered date
2021 Year 03 Month 16 Day
Last modified on
2021 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049833

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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