UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046031
Receipt No. R000052542
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
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Preinitiation
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
2021 Year 11 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.