UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042908 |
|---|---|
| Receipt number | R000048982 |
| Scientific Title | Exploration of predictive biomarkers in checkpoint inhibitor, nivolumab, for recurrent esophageal squamous cell carcinoma after standard therapy |
| Date of disclosure of the study information | 2021/01/05 |
| Last modified on | 2023/01/10 08:08:05 |
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Basic information
Public title
Exploration of predictive biomarkers in checkpoint inhibitor, nivolumab, for recurrent esophageal squamous cell carcinoma after standard therapy
Acronym
E-CIRCUIT
Scientific Title
Exploration of predictive biomarkers in checkpoint inhibitor, nivolumab, for recurrent esophageal squamous cell carcinoma after standard therapy
Scientific Title:Acronym
E-CIRCUIT
Region
| Japan |
Condition
Condition
Esophageal squamous cell carcinoma
Classification by specialty
| Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploration of predictive biomarkers in nivolumab
Basic objectives2
Others
Basic objectives -Others
Local control rate
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immunologic parameters
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 with esophageal squamous cell carcinoma who were treated with nivolumab in Department of Gastrointestinal Tract Surgery, Fukushima Medical University Hospital.
Key exclusion criteria
None.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kono |
Organization
Fukushima Medical University
Division name
Department of Gastrointestinal Tract Surgery
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima city, Fukushima
TEL
024-547-1259
kojikono@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kosaku |
| Middle name | |
| Last name | Mimura |
Organization
Fukushima Medical University
Division name
Department of Gastrointestinal Tract Surgery
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima city, Fukushima
TEL
024-547-1259
Homepage URL
kmimura@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Fukushima
Tel
024-547-1111
c-kiban@fmu.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 05 | 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
16
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
| 2020 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2021 | Year | 01 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048982
