UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026425
Receipt number R000030359
Scientific Title A prospective observational biomarker study for lung cancer immunotherapy
Date of disclosure of the study information 2017/03/06
Last modified on 2022/09/09 12:12:05

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Basic information

Public title

A prospective observational biomarker study for lung cancer immunotherapy

Acronym

Immuno-Oncology Biomarker Study (LC-SCRUM-IBIS)

Scientific Title

A prospective observational biomarker study for lung cancer immunotherapy

Scientific Title:Acronym

Immuno-Oncology Biomarker Study (LC-SCRUM-IBIS)

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

This Study is intended to analyze the expression of PD-L1 and changes in various somatic genes associated with lung cancer, and by evaluating the relationship between the results of such analysis and clinicopathologic factors, therapeutic effects, and prognosis, and to explore new biomarkers for immune therapies for treatment of lung cancer.

Basic objectives2

Others

Basic objectives -Others

The incidence of expression of PD-L1 in lung cancer

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The incidence of expression of PD-L1 in lung cancer

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

1) Patients with a pathologic diagnosis of lung cancer (either biopsy or cytological diagnosis);
2) Patients who are or will be enrolled in one of the 3 observational studies of LC-SCRUM-Japan, and at the same time, in whom fresh frozen sample + 10 slides of unstained preparation for genetic analysis and blood samples can be collected; and
3) Patients who consent in writing to take part in the Study.

Key exclusion criteria

Not applicable

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Goto

Organization

National Cancer Center Hospital East

Division name

Department of Thoracic Oncology

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan

TEL

04-7133-1111

Email

kgoto@east.ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kiyotaka Yoh

Organization

National Cancer Center Hospital East

Division name

Department of Thoracic Oncology

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan

TEL

04-7133-1111

Homepage URL


Email

kyoh@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



Funding Source

Organization

ONO PHARMACEUTICAL CO., LTD.
CHUGAI PHARMACEUTICAL CO., LTD.
AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

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

2017 Year 03 Month 06 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

2017 Year 01 Month 25 Day

Date of IRB

2017 Year 01 Month 24 Day

Anticipated trial start date

2017 Year 02 Month 14 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The incidence of expression of PD-L1 in lung cancer


Management information

Registered date

2017 Year 03 Month 06 Day

Last modified on

2022 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030359


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name