UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054414 |
|---|---|
| Receipt number | R000062150 |
| Scientific Title | A retrospective study about the efficacy of PA/A ratio as a prognostic factor for Stage0-I non-small cell lung cancer |
| Date of disclosure of the study information | 2024/05/16 |
| Last modified on | 2025/05/19 16:32:37 |
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Basic information
Public title
A retrospective study about the efficacy of PA/A ratio as a prognostic factor for Stage0-I non-small cell lung cancer
Acronym
A retrospective study about the efficacy of PA/A ratio as a prognostic factor for Stage0-I non-small cell lung cancer
Scientific Title
A retrospective study about the efficacy of PA/A ratio as a prognostic factor for Stage0-I non-small cell lung cancer
Scientific Title:Acronym
A retrospective study about the efficacy of PA/A ratio as a prognostic factor for Stage0-I non-small cell lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the usefulness of preoperative PA/A ratio as a prognostic factor for pathological Tis-1cN0M0 non-small cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
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
Patients who underwent complete resection for pathological Tis-1cN0M0 NSCLC between January 2013 and December 2018.
Key exclusion criteria
Patients with receiving induction therapy, previous lung resection, or the presence of simultaneous or metachronous cancers.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Nishikubo |
Organization
Hyogo Cancer Center
Division name
Division of chest surgery
Zip code
673-0021
Address
13-70, Kitaoji-cho, Akashi, Hyogo, 673-0021, Japan
TEL
+81-78-929-1151
megumis0512@gmail.com
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Nishikubo |
Organization
Hyogo Cancer Center
Division name
Division of chest surgery
Zip code
673-0021
Address
13-70, Kitaoji-cho, Akashi, Hyogo, 673-0021, Japan
TEL
+81-78-929-1151
Homepage URL
megumis0512@gmail.com
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Hyogo Cancer Center
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
Hyogo Cancer Center
Address
13-70, Kitaoji-cho, Akashi, Hyogo, 673-0021, Japan
Tel
+81-78-929-1151
rinsyoshikenkanri6@hyogo-cc.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 | 05 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2666273624003887?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2666273624003887?via%3Dihub
Number of participants that the trial has enrolled
322
Results
Of the 319 included patients, 116 were categorized into the high-ratio group and 203 into the low-ratio group. After propensity score matching, OS was significantly worse in the high-ratio group than in the low-ratio group (5-year OS: 89.4% vs. 96.2%; P = 0.006). The high-ratio group had a significantly higher non-lung cancer-related death incidence than the low-ratio group (P = 0.01).
Results date posted
| 2025 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Before propensity score matching, PA/A high ratio group had significantly more patients with interstitial changes and higher BMI.
After propensity score matching, all relevant variables except for the pathological stage (standardized mean difference [SMD] = 0.12) were confirmed to be well-matched.
Participant flow
In total, 600 patients underwent complete resection of pathological Tis-1cN0M0 NSCLC between January 2013 and December 2018. Among the 600 patients, 319 were eligible, after excluding those with simultaneous or metachronous cancers and those with a history of thoracic surgery. Of the 319 included patients, 116 were categorized into the high-ratio group and 203 into the low-ratio group. The number of patients who underwent echocardiography as a preoperative assessment was 155.
Adverse events
Not applicable
Outcome measures
OS was significantly worse in the high-ratio group than in the low-ratio group.
In the high-ratio group, 6 lung cancer-related deaths and 14 other causes of death were recorded, whereas in the low-ratio group, 3 lung cancer-related deaths and 3 other causes of death occurred. Although the cumulative incidence of lung cancer did not differ between the two study groups, the incidence of competing causes of death was significantly higher in the high-ratio group than in the low-ratio group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Records of eligible patients at Hyogo Cancer Center were reviewed.
Management information
Registered date
| 2024 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062150
