UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043637 |
|---|---|
| Receipt number | 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 | 2024/03/18 07:18:46 |
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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
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
ohashish@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049833
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
