UMIN-CTR Clinical Trial

Basic information
Public title	The prospective study of blood biomarker and gut microbiota in the patients treated with anti-PD 1 antibody for advanced non-small cell lung cancer
Acronym	Biomarker study for nivolumab
Scientific Title	The prospective study of blood biomarker and gut microbiota in the patients treated with anti-PD 1 antibody for advanced non-small cell lung cancer
Scientific Title:Acronym	Biomarker study for nivolumab
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to elucidate plasma soluble PD-L1 or other biomaker in the advanced NSCLC patients treated with nivolumab.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To investigate correlation between soluble PD-L1 or other biomarkers and clinical response or toxicities
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	18 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion criterion of the present study is the patients who treated with chemotherapy at Komagome Hospital. Before being underwent chemotherapy, the patients examined blood sample with tube (or EDTA) contains sodium heparin of up to 14mL and/or fece.
Key exclusion criteria	Other than that above
Target sample size	64

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Okuma
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology and Respiratory Medicine
Zip code	113-8677
Address	Honkomagome 3-18-22, Bunkyo, Tokyo
TEL	03-3823-2101
Email	y-okuma@cick.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Okuma
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology and Respiratory Medicine
Zip code	113-8677
Address	Honkomagome 3-18-22, Bunkyo, Tokyo
TEL	03-3823-2101
Homepage URL
Email	y-okuma@cick.jp

Sponsor
Institute	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Institut Gustave Roussy
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of Tokyo Metropolitan Komagome Hospital
Address	3-28-22, Honkomagome, Bunkyo, Tokyo
Tel	03-3823-2101
Email	rinri@cick.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	がん・感染症センター都立駒込病院（東京）

Other administrative information
Date of disclosure of the study information	2016 Year 05 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	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 01 Day
Date of IRB	2016 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2023 Year 09 Month 30 Day
Date of closure to data entry	2023 Year 09 Month 30 Day
Date trial data considered complete	2023 Year 12 Month 30 Day
Date analysis concluded	2024 Year 03 Month 31 Day

Other
Other related information	We have already reported the result of soluble PD-L1 in non-small cell lung cancer demonstrated to be associated with poor prognosis. Therefore, we explore to detect biomarker including soluble PD-L1 or VEGF in the patients with nivolumab and investigate association with clinical outcome or characteristics.

Management information
Registered date	2016 Year 04 Month 01 Day
Last modified on	2020 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025027