UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055609 |
|---|---|
| Receipt number | R000063546 |
| Scientific Title | A Multicenter, Retrospective Study on Testing for Actionable Oncogenic Drivers and Molecular Targeted Therapies in Non-Small Cell Lung Cancer with Comorbid Interstitial Pneumonia |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/10/07 08:54:18 |
* 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
A Multicenter, Retrospective Study on Testing for Actionable Oncogenic Drivers and Molecular Targeted Therapies in Non-Small Cell Lung Cancer with Comorbid Interstitial Pneumonia
Acronym
A Multicenter, Retrospective Study on Testing for Actionable Oncogenic Drivers and Molecular Targeted Therapies in NSCLC with Comorbid IP
Scientific Title
A Multicenter, Retrospective Study on Testing for Actionable Oncogenic Drivers and Molecular Targeted Therapies in Non-Small Cell Lung Cancer with Comorbid Interstitial Pneumonia
Scientific Title:Acronym
A Multicenter, Retrospective Study on Testing for Actionable Oncogenic Drivers and Molecular Targeted Therapies in NSCLC with Comorbid IP
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer with Comorbid Interstitial Pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the implementation status of Testing for Actionable Oncogenic Drivers in Non-Small Cell Lung Cancer with Comorbid Interstitial Pneumonia
To clarify the frequency of each actionable oncogenic drivers and the safety/effectiveness of each molecular targeted therapies in Non-Small Cell Lung Cancer with comorbid Interstitial Pneumonia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implementation rate of Testing for Actionable Oncogenic Drivers in Non-Small Cell Lung Cancer with Comorbid Interstitial Pneumonia
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
1. Pathologically diagnosed Non-Small Cell Lung Cancer (NSCLC) by cytological or histological diagnosis.
2. Unresectable stage III/IV/postoperative recurrence
3. If stage III/IV, the examination that led to the diagnosis of NSCLC was conducted between June 1, 2019 and June 30, 2024. If postoperative recurrence, the diagnosis of postoperative recurrence was made between June 1, 2019 and June 30, 2024
4. The attending physician or the responsible physician/sub-investigator at each institutions has diagnosed the patient as having chronic fibrosing interstitial pneumonia in the background lung
5. Idiopathic interstitial pneumonia or any of the following secondary interstitial pneumonias ([1] fibrosing hypersensitivity pneumonitis, [2] occupational lung disease/pneumoconiosis, [3] collagen vascular disease/vasculitis)
Key exclusion criteria
1. Iatrogenic secondary interstitial pneumonia (1. radiation pneumonitis, 2. drug-induced pneumonitis, 3. other)
2. Interstitial Lung Abnormality identified retrospectively
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Kishi |
Organization
Toho University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3762-4151
kazuma.kishi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ikeda |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
236-0051
Address
6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama
TEL
045-701-9581
Homepage URL
isatoshi0112@gmail.com
Sponsor or person
Institute
The Diffuse Lung Diseases Research Group from the Ministry of Health, Labour, and Welfare in Japan
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Kanagawa Cardiovascular and Respiratory Center
Address
6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama
Tel
045-701-9581
onoda.3810g@kanagawa-pho.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
| 2024 | Year | 10 | 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
| 2024 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Multicenter, Retrospective Study
Management information
Registered date
| 2024 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063546
