UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017172 |
|---|---|
| Receipt number | R000019925 |
| Scientific Title | Subtype classification of superficial esophageal cancer from gene expression profile |
| Date of disclosure of the study information | 2015/04/19 |
| Last modified on | 2020/04/22 09:08:37 |
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Basic information
Public title
Subtype classification of superficial esophageal cancer from gene expression profile
Acronym
Subtype classification of superficial esophageal cancer
Scientific Title
Subtype classification of superficial esophageal cancer from gene expression profile
Scientific Title:Acronym
Subtype classification of superficial esophageal cancer
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To classify superficial esophageal cancer based on risk factors, endoscopic characteristics and gene expression of pretreatment biopsy sample
Basic objectives2
Others
Basic objectives -Others
prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subtype classification of superficial esophageal cancer based on gene expression profiles, risk factors and endoscopic characteristics
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
1)Patients with superficial esophageal cancer who will undergo endoscopic resection, surgery or chemoradiotherapy
2)Squamous cell carcinoma
3)Written informed consent is obtained
Key exclusion criteria
1)Adenocarcinoma, small cell carcinoma or neuroendocrine carcinoma
2)Patients who have history of chemotherapy
3)Patients who have history of radiation therapy to the chest or mediastinum
4)Patients who have received antiplatelet agent or anticoagulation agent
5)Patients who have too small superficial esophageal cancer to take biopsy sample
6)Patient who are pregnant
7)Patients who have been judged as in appropriate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Ishihara |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL
+81-6-6972-1181
isihara-ry@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Yamasaki |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL
+81-6-6972-1181
Homepage URL
yamazaki-ya@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Not yet confirmed
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Research Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪府立成人病センター（大阪府）、国立がん研究センター研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2015 | Year | 04 | Month | 19 | Day |
Last modified on
| 2020 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019925
| Research Plan | |
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| 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 |
