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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name