UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033227 |
|---|---|
| Receipt number | R000037888 |
| Scientific Title | Investigation for the risk factors of lymph node or organ metastasis in esophageal cancer |
| Date of disclosure of the study information | 2018/07/20 |
| Last modified on | 2025/01/06 08:17:10 |
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Basic information
Public title
Investigation for the risk factors of lymph node or organ metastasis in esophageal cancer
Acronym
Investigation for the risk factors of metastasis in esophageal cancer
Scientific Title
Investigation for the risk factors of lymph node or organ metastasis in esophageal cancer
Scientific Title:Acronym
Investigation for the risk factors of metastasis in esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the risk factors of metastasis in esophageal cancer
Basic objectives2
Others
Basic objectives -Others
Incidence of metastasis in subgroups stratified by risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors of metastasis
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
1) Endoscopically resected esophageal cancer between January 2003 and December 2017.
2) Invasion depth of MM or SM
Key exclusion criteria
1) No local recurrence after endoscopic resection.
2) No esophagectomy, radiation or chemotherapy before endoscopic resection.
Target sample size
780
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Ishihara |
Organization
Osaka International Cancer Institute
Division name
Gastrointestinal oncology
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
ryu1486@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryu Ishihara |
Organization
Osaka International Cancer Institute
Division name
Gastrointestinal oncology
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
Homepage URL
ryu1486@gmail.com
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Seijinbyo yoboukyoukai
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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
J Gastroenterol. 2024 Nov 26. doi: 10.1007/s00535-024-02189-6. Online ahead of print.
Number of participants that the trial has enrolled
422
Results
Metastases were identified in 103 patients. Univariate analysis identified LVI, depth of invasion, and DI as significant predictive factors. Multivariate analysis identified LVI, depth of invasion pT1b-SM2 (odds ratio 2.72) and indeterminate (positive vertical margin) (odds ratio 3.63) compared with the reference category of pT1b-SM1 as independent predictors of metastasis.
Results date posted
| 2025 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 11 | Month | 26 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037888
