UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057193 |
|---|---|
| Receipt number | R000065230 |
| Scientific Title | Retrospective analysis of long-term prognostic factors for non-small cell lung cancer with EGFR gene mutation in Nagano Prefecture |
| Date of disclosure of the study information | 2025/03/05 |
| Last modified on | 2025/03/03 20:59:10 |
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Basic information
Public title
Retrospective analysis of long-term prognostic factors for non-small cell lung cancer with EGFR gene mutation in Nagano Prefecture
Acronym
Retrospective analysis of long-term prognostic factors for non-small cell lung cancer with EGFR gene mutation in Nagano Prefecture (Re ALPS)
Scientific Title
Retrospective analysis of long-term prognostic factors for non-small cell lung cancer with EGFR gene mutation in Nagano Prefecture
Scientific Title:Acronym
Retrospective analysis of long-term prognostic factors for non-small cell lung cancer with EGFR gene mutation in Nagano Prefecture (Re ALPS)
Region
| Japan |
Condition
Condition
non-small cell lung cancer with EGFR gene mutation
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In cases of lung cancer with positive EGFR gene mutations, we will examine the patient background and factors in cases where EGFR-TKI was used in treatment and achieved long-term efficacy for over 5 years.
Basic objectives2
Others
Basic objectives -Others
We will examine the relationship between the site of occurrence, maximum tumor diameter, sites of metastasis, types of genetic mutations, treatment content after second-line therapy and the use of ICI or EGFR-TKI, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, GPS (Glasgow Prognostic Score), PNI (Prognostic Nutritional Index), and other related factors in long-term efficacy cases of EGFR-TKI.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NLR (Neutrophil-to-Lymphocyte Ratio)
Key secondary outcomes
Site of occurrence, maximum tumor diameter, site of metastasis, type of genetic mutation, treatment details after secondary treatment and whether ICI or EGFR-TKI was used, PLR(Platelet-to-Lymphocyte Ratio), GPS(Glasgow Prognostic Score), PNI(Prognostic Nutritional Index), etc.
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
(1) Cases of non-small cell lung cancer that have been proven histologically or cytologically and are subject to medical treatment.
(2) Mutations are recognized in approved companion diagnostics using tumor tissue or cells.
(3) Age is 20 years or older.
Key exclusion criteria
Those deemed inappropriate for participation in this research by the principal investigator or research collaborators.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tateishi |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture, Japan.
TEL
0263-37-2631
tateishi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Yanagisawa |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture, Japan.
TEL
0263-37-2631
Homepage URL
6367katsu@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Certified Review Board of Clinical Research
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture, Japan.
Tel
0263-37-2572
md_rinri@shinshu-u.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
| 2025 | Year | 03 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to examine the patient background and factors in cases of lung cancer with positive EGFR gene mutations that have been treated with EGFR-TKI and have shown long-term efficacy for over five years.
Management information
Registered date
| 2025 | Year | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065230
