UMIN-CTR Clinical Trial

Basic information
Public title	Association of circulating tumor cell gene mutations and peripheral blood lymphocyte telomere length with the frequency and severity of immune-related pneumonitis in lung cancer patients receiving cancer immunotherapy
Acronym	Association of circulating tumor cell gene mutations and peripheral blood lymphocyte telomere length with the frequency and severity of immune-related pneumonitis in lung cancer patients receiving cancer immunotherapy
Scientific Title	Association of circulating tumor cell gene mutations and peripheral blood lymphocyte telomere length with the frequency and severity of immune-related pneumonitis in lung cancer patients receiving cancer immunotherapy
Scientific Title:Acronym	Association of circulating tumor cell gene mutations and peripheral blood lymphocyte telomere length with the frequency and severity of immune-related pneumonitis in lung cancer patients receiving cancer immunotherapy
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology Adult
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the association between driver gene mutations of circulating tumor DNA (ctDNA) in blood and telomere length of peripheral blood lymphocytes in lung cancer patients and the frequency and severity of immune-related pneumonitis during cancer immunotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency and severity of immune-related pneumonitis during cancer immunotherapy.
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	The patient who has been histopathologically diagnosed with lung cancer. The patient who are planning to undergo cancer immunotherapy.
Key exclusion criteria	Those who do not consent to the research.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Kohei Middle name Last name Fujita
Organization	National Hospital Organization Kyoto Medical Center
Division name	Respiratory Medicine
Zip code	612-8555
Address	1-1, Fukakusa-Mukaihata, Fushimi-Ku, Kyoto, Japan
TEL	0756419161
Email	kfujita.acd@gmail.com

Public contact
Name of contact person	1st name Kohei Middle name Last name Fujita
Organization	NHO Kyoto Medical Center
Division name	Respiratory Medicine
Zip code	612-8555
Address	1-1, Fukakusa-Mukaihata, Fushimi-Ku, Kyoto, Japan
TEL	0756419161
Homepage URL
Email	kfujita.acd@gmail.com

Sponsor
Institute	NHO Kyoto Medical Center
Institute
Department

Funding Source
Organization	NHO Kyoto Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	MiRTel Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NHO Kyoto Medical Center
Address	1-1, Fukakusa-Mukaihata, Fushimi-Ku, Kyoto, Japan
Tel	0756419161
Email	yamaji.hirofumi.bg@mail.hosp.go.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	国立病院機構京都医療センター

Other administrative information
Date of disclosure of the study information	2021 Year 12 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	Open public recruiting
Date of protocol fixation	2021 Year 11 Month 15 Day
Date of IRB	2021 Year 11 Month 15 Day
Anticipated trial start date	2021 Year 12 Month 01 Day
Last follow-up date	2024 Year 12 Month 01 Day
Date of closure to data entry	2025 Year 12 Month 01 Day
Date trial data considered complete	2025 Year 12 Month 01 Day
Date analysis concluded	2025 Year 12 Month 31 Day

Other
Other related information	To investigate the association between driver gene mutations of circulating tumor DNA (ctDNA) in blood and telomere length of peripheral blood lymphocytes in lung cancer patients and the frequency and severity of immune-related interstitial pneumonia during cancer immunotherapy.

Management information
Registered date	2021 Year 11 Month 10 Day
Last modified on	2022 Year 03 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052542