UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046031 |
|---|---|
| Receipt number | 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 | 2022/03/21 11:19:07 |
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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
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
kfujita.acd@gmail.com
Sponsor or person
Institute
NHO Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052542
