UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061253 |
|---|---|
| Receipt number | R000070092 |
| Scientific Title | The prospective observational study to evaluate the relationships between thoracic motion and respiratory function after lung cancer surgery |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/14 12:11:55 |
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Basic information
Public title
The prospective observational study to evaluate the relationships between thoracic motion and respiratory function after lung cancer surgery
Acronym
The relationships between thoracic motion and respiratory function after lung cancer surgery
Scientific Title
The prospective observational study to evaluate the relationships between thoracic motion and respiratory function after lung cancer surgery
Scientific Title:Acronym
The relationships between thoracic motion and respiratory function after lung cancer surgery
Region
| Japan |
Condition
Condition
Resectable non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate how the surgical approach, procedure, and resection site for primary lung cancer affect postoperative respiratory function through alterations in thoracic cage and diaphragmatic motion.
Basic objectives2
Others
Basic objectives -Others
We further investigated the effects of underlying pulmonary conditions, including COPD and interstitial lung disease, as well as smoking history, on postoperative thoracic cage motion and respiratory function, independent of surgical factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of lung cancer surgery on thoracic motion and lung volume
Key secondary outcomes
Effects of lung comorbidity and postoperative complications on thoracic motion and lung volume
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
This study includes patients who underwent lung cancer surgery between January 1, 2022, and December 31, 2023, and received preoperative dynamic X-ray imaging.
Key exclusion criteria
1. Cases for which X-ray dynamic imaging cannot be performed for any reason
2. Cases of death occurring within 30 days of surgery
3. Cases where participation in the study is deemed difficult
4. Cases deemed unsuitable for this study by the attending physician
5. Cases of patients who have expressed their refusal to participate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Ito |
Organization
Matsusaka Municipal Hospital
Division name
Department of Thoracic Surgery, Respiratory Center
Zip code
515-8544
Address
1550 Tonomachi Matsusaka, Mie, Japan, 515-8544
TEL
0598-23-1515
mchi.atsushi@city-hosp.matsusaka.mie.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Ito |
Organization
Matsusaka Municipal Hospital
Division name
Department of Thoracic Surgery, Respiratory Center
Zip code
515-8544
Address
1550 Tonomachi Matsusaka, Mie, Japan, 515-8544
TEL
0598-23-1515
Homepage URL
mchi.atsushi@city-hosp.matsusaka.mie.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Respiratory Center, Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
This research was conducted in the absence of any commercial or financial relationships.
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
Institutional Review Board of Matsusaka Municipal Hospital
Address
1550 Tonomachi Matsusaka, Mie, Japan, 515-8544
Tel
0598-23-1515
mch1031@city-hosp.matsusaka.mie.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
| 2026 | Year | 04 | Month | 20 | 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
99
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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient Information: Identification code, age, sex, smoking index, medical history, clinical stage at diagnosis (TNM Classification, 8th Edition), PS (ECOG performance status)
Surgical Information: Date of surgery, type of surgery, resection method, side of resection, resection site
Pathology Information: Pathological stage (TNM Classification, 8th Edition), histological type, total tumor diameter, invasive depth, grade of differentiation, presence of venous invasion, presence of lymphatic invasion, presence of pleural invasion, presence of intrathoracic metastasis, presence of spread through alveolar space (STAS), immunohistochemical testing, etc.
Laboratory and Imaging Information: Chest X-ray, dynamic X-ray, CT, PET-CT, pulmonary function tests, electrocardiogram (ECG), echocardiogram, etc.
Hospitalization History: Postoperative complications, presence or absence of pleural adhesion therapy
Outcome Information: Date of survival confirmation, presence or absence of recurrence, date of recurrence, date of death, cause of death
Management information
Registered date
| 2026 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070092
