UMIN-CTR Clinical Trial

Basic information
Public title	Comprehensive analysis of blood tryptophan metabolites and fatty acids in patients with lung cancer treated with immune checkpoint inhibitors
Acronym	Tryptophan metabolites and fatty acids in ICI
Scientific Title	Comprehensive analysis of blood tryptophan metabolites and fatty acids in patients with lung cancer treated with immune checkpoint inhibitors
Scientific Title:Acronym	Tryptophan metabolites and fatty acids in ICI
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility of tryptophan metabolites and fatty acids for predicting efficacy of immune checkpoint inhibitors
Basic objectives2	Others
Basic objectives -Others	Biomarker
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Levels of blood tryptophan metabolites and fatty acids
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	Pathologically diagnosed non-small cell lung cancer patients who received immune checkpoint inhibitors
Key exclusion criteria	Insufficient blood samples.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Suda
Organization	Hamamatsu University School of Medicine
Division name	Second division, Department of Internal Medicine
Zip code	431-3192
Address	Handayama 1-20-1, Hamamatsu
TEL	053-435-2111
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Masato Middle name Last name Karayama
Organization	Hamamatsu University School of Medicine
Division name	Department of Chemotherapy
Zip code	431-3192
Address	Handayama 1-20-1, Hamamatsu
TEL	053-435-2111
Homepage URL
Email	karayama@hama-med.ac.jp

Sponsor
Institute	Second division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board of Hamamatsu University School of Medicine
Address	Handayama 1-20-1, Hamamatsu
Tel	053-435-2111
Email	kenkyou.k@hama-med.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	2020 Year 01 Month 20 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	Completed
Date of protocol fixation	2019 Year 06 Month 07 Day
Date of IRB	2019 Year 06 Month 07 Day
Anticipated trial start date	2019 Year 06 Month 07 Day
Last follow-up date	2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2020 Year 01 Month 17 Day
Last modified on	2022 Year 07 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044692