UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058449 |
|---|---|
| Receipt number | R000066821 |
| Scientific Title | A retrospective study about the adequate margin distance of sublobar resection for patients with non-small cell lung cancer |
| Date of disclosure of the study information | 2025/07/13 |
| Last modified on | 2026/09/10 14:06:14 |
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Basic information
Public title
A retrospective study about the adequate margin distance of sublobar resection for patients with non-small cell lung cancer
Acronym
A retrospective study about the adequate margin distance of sublobar resection for patients with non-small cell lung cancer
Scientific Title
A retrospective study about the adequate margin distance of sublobar resection for patients with non-small cell lung cancer
Scientific Title:Acronym
A retrospective study about the adequate margin distance of sublobar resection for patients with 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 relationship between the margin distance and the loco-regional recurrence of sublobar resection for patients with non-small cell lung cancer.
Basic objectives2
Others
Basic objectives -Others
To compare the loco-regional recurrence rate between sublobar resection and lobectomy in terms of margin distance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Freedom from the loco-regional recurrence
Key secondary outcomes
cumulative incidence of loco-regional recurrence
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 < 3cm adenocarcinoma, squamous cell carcinoma, and adenosquamous cell carcinoma between April 2018 and March 2024.
Key exclusion criteria
Patients receiving induction therapy, underwent combined resection of chest wall, pathologically confirmed lymph node metastasis, intrapulmonary metastasis, or interlobular pl3, presence of multiple lung cancers, or margin distance unreported.
Target sample size
500
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
673-8558
Address
13-70 Kitaoji-cho, Akashi City, Hyogo, 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
673-8558
Address
13-70 Kitaoji-cho, Akashi City, Hyogo, 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 City, Hyogo, Japan, 673-8558
Tel
+81-78-929-1151
rinsyoshikenkanri5@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
| 2025 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
https://academic.oup.com/icvts/article/41/2/ivag045/8472253?login=true
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/icvts/article/41/2/ivag045/8472253?login=true
Number of participants that the trial has enrolled
528
Results
In the overall cohort, LRR risk was worse in the insufficient margin group than in the sufficient margin and lobectomy groups, whereas the risk in the sufficient margin group was similar to the lobectomy groups. Conversely, in the pure-solid cohort, the risk of LRR was worse in the insufficient margin group and even in the sufficient margin group, compared to the lobectomy group.
Results date posted
| 2026 | Year | 09 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
200 patients underwent sublobar resection and 328 patients who underwent lobectomy. The proportion of male sex, pathologically advanced stages and high metabolic tumours was higher in patients who underwent lobectomy.
Participant flow
In total, 725 patients underwent complete resection of pathological <3 cm adenocarcinoma, squamous cell carcinoma and adenosquamous cell carcinoma. Among them, 528 patients were eligible, after excluding 197 patients who received induction therapy, underwent combined resection of chest wall, had interlobular pl3 tumours, had pathologically confirmed lymph node metastasis or intrapulmonary metastasis, had multiple lung cancers or with margin distance unreported.
Adverse events
Not analyzed
Outcome measures
The incidence of loco-regional recurrence
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 18 | 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
| 2025 | Year | 07 | Month | 13 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066821
