UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059277 |
|---|---|
| Receipt number | R000067807 |
| Scientific Title | Radiological Features of Visceral Pleural Invasion (VPI) in Primary Lung Cancer on Preoperative Chest CT: A Retrospective Observational Study |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/10/03 21:06:16 |
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Basic information
Public title
Study on Chest CT Findings Predictive of Visceral Pleural Invasion (VPI) in Lung Cancer
Acronym
Lung-VPI Study
Scientific Title
Radiological Features of Visceral Pleural Invasion (VPI) in Primary Lung Cancer on Preoperative Chest CT: A Retrospective Observational Study
Scientific Title:Acronym
PRE-VPI
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the association between preoperative CT imaging features and pathological visceral pleural invasion (VPI) in non-small cell lung cancer with ground-glass opacity components.
Basic objectives2
Others
Basic objectives -Others
To evaluate diagnostic accuracy for pathological VPI based on preoperative CT features and to explore associated risk factors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of pathological visceral pleural invasion (VPI), determined from postoperative histopathological examination of resected specimens.
(Time frame: At the time of surgery)
Key secondary outcomes
To evaluate relapse-free survival (RFS) and overall survival (OS) according to the presence or absence of visceral pleural invasion (VPI).
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
| 18 | years-old | <= |
Age-upper limit
| 999 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent surgical resection for primary lung cancer at [Okayama university hospital] from January 1, 2012 to December 31, 2019, with a final pathological diagnosis of non-small cell lung cancer (NSCLC).
Lesions meeting all of the following:
1.Contact with the visceral pleura on preoperative thin-section CT (slice thickness <= 2.5 mm)
2.Part-solid or pure ground-glass nodules with solid component diameter <=30 mm
3.Age =>18 years at presentation
Key exclusion criteria
1.Any neoadjuvant therapy prior to surgery
2.Final pathology other than NSCLC
3.Lack of thin-section CT or indeterminate pleural contact
4.Solid component diameter <30 mm
5.Missing data precluding assessment of the primary outcome (pathological VPI)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Toyooka |
Organization
Okayama University Hospital
Division name
Department of General Thoracic Surgery and Brest and Endocrinological Surgery
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
+81-86-235-7265
toyooka@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | naohiro |
| Middle name | |
| Last name | hayashi |
Organization
Okayama University Hospital
Division name
Department of General Thoracic Surgery and Brest and Endocrinological Surgery
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
+81-86-235-7265
Homepage URL
pqak0q2o@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
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
Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-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
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 06 | 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
299
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective cohort study
Management information
Registered date
| 2025 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067807
