UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033594
Receipt number R000037875
Scientific Title Investigation of post-treatment after immune checkpoint inhibitor treatment for advanced or recurrent non-small cell lung cancer
Date of disclosure of the study information 2018/08/01
Last modified on 2018/08/01 18:45:23

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Basic information

Public title

Investigation of post-treatment after immune checkpoint inhibitor treatment for advanced or recurrent non-small cell lung cancer

Acronym

Investigation of post-treatment after immune checkpoint inhibitor treatment for advanced or recurrent non-small cell lung cancer

Scientific Title

Investigation of post-treatment after immune checkpoint inhibitor treatment for advanced or recurrent non-small cell lung cancer

Scientific Title:Acronym

Investigation of post-treatment after immune checkpoint inhibitor treatment for advanced or recurrent non-small cell lung cancer

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Investigation of the characteristics of clinical, image, therapeutic agents, etc. for cases after treatment with immune checkpoint inhibitors for advanced or recurrent non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Response rate

Key secondary outcomes

Progression-free survival
Overall survival
Side effect
Types of immunity checkpoint inhibitors
Types of anti-cancer drugs


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

Advanced or recurrent non-small cell lung cancer in which an immune check point inhibitor was used at our center

Key exclusion criteria

Patient, or family refuses to participate in the study

Target sample size

37


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takehiro Izumo

Organization

Japanese Red Cross Medical Center

Division name

Respiratory Medicine

Zip code


Address

4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan

TEL

03-3400-1311

Email

drtake1118@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Mari Tone

Organization

Japanese Red Cross Medical Center

Division name

Respiratory Medicine

Zip code


Address

4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan

TEL

03-3400-1311

Homepage URL


Email

m.tone.0829@gmail.com


Sponsor or person

Institute

Japanese Red Cross Medical Center

Institute

Department

Personal name



Funding Source

Organization

Japanese Red Cross Medical Center

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


Address


Tel


Email



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 08 Month 01 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

2016 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 01 Day

Last follow-up date

2018 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 09 Month 30 Day


Other

Other related information

Single facility observational study


Management information

Registered date

2018 Year 08 Month 01 Day

Last modified on

2018 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037875


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name