UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048382 |
|---|---|
| Receipt number | R000055136 |
| Scientific Title | Development and Validation of a Predictive Nomogram of Disease Recurrence after Esophagectomy in Patients with Esophageal Squamous Cell Carcinoma Who Received Neoadjuvant Treatment |
| Date of disclosure of the study information | 2022/07/15 |
| Last modified on | 2024/04/29 20:47:17 |
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Basic information
Public title
Development and Validation of a Predictive Nomogram of Disease Recurrence after Esophagectomy in Patients with Esophageal Squamous Cell Carcinoma Who Received Neoadjuvant Treatment
Acronym
Development and Validation of a Predictive Nomogram of Disease Recurrence after Esophagectomy in Patients with Esophageal Squamous Cell Carcinoma Who Received Neoadjuvant Treatment
Scientific Title
Development and Validation of a Predictive Nomogram of Disease Recurrence after Esophagectomy in Patients with Esophageal Squamous Cell Carcinoma Who Received Neoadjuvant Treatment
Scientific Title:Acronym
Development and Validation of a Predictive Nomogram of Disease Recurrence after Esophagectomy in Patients with Esophageal Squamous Cell Carcinoma Who Received Neoadjuvant Treatment
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development and Validation of a Predictive Nomogram of Disease Recurrence after Esophagectomy in Patients with Esophageal Squamous Cell Carcinoma Who Received Neoadjuvant Treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease Recurrence after Esophagectomy
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 received neoadjuvant treatment followed by curative surgery for esophageal cancer
Key exclusion criteria
Salvage surgery
R1-2 resection
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Watanabe |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
Division name
Department of Esophageal Surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
0335200111
masayuki.watanabe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Okamura |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
Division name
Department of Esophageal Surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
0335200111
Homepage URL
akihiko.okamura@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation for Cancer Research, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional review board of JFCR
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
Tel
0335200111
med.shinsa@jfcr.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-1
Org. issuing International ID_1
Japan Esophageal Society
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 15 | 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
4781
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055136
