UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053694 |
|---|---|
| Receipt number | R000061271 |
| Scientific Title | Examination of postoperative cardiac function by operative method of pulmonary resection |
| Date of disclosure of the study information | 2024/02/24 |
| Last modified on | 2024/02/24 00:00:55 |
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Basic information
Public title
Examination of postoperative cardiac function by operative method of pulmonary resection
Acronym
Examination of postoperative cardiac function by operative method of pulmonary resection
Scientific Title
Examination of postoperative cardiac function by operative method of pulmonary resection
Scientific Title:Acronym
Examination of postoperative cardiac function by operative method of pulmonary resection
Region
| Japan |
Condition
Condition
Patients who plan to perform pulmonary resection for clinically suspected lung cancer
Classification by specialty
| Cardiology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial is to evaluate the postoperative change of cardiopulmonary function between patients undergoing lobectomy and sublobar resection by exercise stress testing.
Basic objectives2
Others
Basic objectives -Others
physiological function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Not applicable. No primary endpoint is used because this trial is exploratory research.
Key secondary outcomes
Not applicable. No secondary endpoint is used because this trial is exploratory research.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Clinically suspected lung cancer on imaging studies.
2) Aged 20 years or older, and 85 years or younger.
3) No prior pulmonary resection.
4) No prior cardiovascular disease.
5) No prior chemotherapy or radiation therapy for any malignant diseases within 5 years. (Hormone therapy is allowed)
6) Functionally fit for lobectomy.
7) PS of 0 to 1.
8) Sufficient organ function.
9) Written informed consent.
Key exclusion criteria
1) Systemic active infection requiring treatment.
2) Lactating, Possibly currently pregnant.
3) Psychosis.
4) Uncontrollable diabetes.
5) Uncontrollable hypertension.
6) There is at least one history of severe heart disease, heart failure, myocardial infarction within 6 months, angina attack within 6 months.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Morihito |
| Middle name | |
| Last name | Okada |
Organization
Hiroshima University
Division name
Department of Surgical Oncology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5869
morihito@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kamigaichi |
Organization
Hiroshima University
Division name
Department of Surgical Oncology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5869
Homepage URL
akamigaichi23@gmail.com
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
Tel
082-257-5555
iryo-sinsa@office.hiroshima-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
| 2024 | Year | 02 | Month | 24 | 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
41
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 | 03 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 02 | Month | 24 | Day |
Last modified on
| 2024 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061271
