UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022708 |
|---|---|
| Receipt number | R000024785 |
| Scientific Title | A prospective observational study of the recurrence rate after treatments for the patients with spontaneous pneumothorax (JNETS1601) |
| Date of disclosure of the study information | 2016/06/13 |
| Last modified on | 2024/12/23 13:41:36 |
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Basic information
Public title
A prospective observational study of the recurrence rate after treatments for the patients with spontaneous pneumothorax (JNETS1601)
Acronym
A prospective observational study of the recurrence rate of spontaneous pneumothorax (JNETS1601)
Scientific Title
A prospective observational study of the recurrence rate after treatments for the patients with spontaneous pneumothorax (JNETS1601)
Scientific Title:Acronym
A prospective observational study of the recurrence rate of spontaneous pneumothorax (JNETS1601)
Region
| Japan |
Condition
Condition
Spontaneous pneumothorax
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A multicenter study to investigate the recurrence rate after treatments for spontaneous pneumothorax
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence rate after treatments
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
| 15 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with primary spontaneous pneumothorax
Key exclusion criteria
Patients with secondary pneumothorax, iatrogenic pneumothorax, traumatic pneumothorax, and female patient with catamenial pneumothorax
Target sample size
238
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Chida |
Organization
Dokkyo Medical University
Division name
Department of General Thoracic Surgery
Zip code
Address
Kitakobayashi 880, Mibu-machi, Shimotoga-gun, Tochigi
TEL
0282-86-1111
chida-ths@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sumiko Maeda |
Organization
Dokkyo Medical University
Division name
Department of General Thoracic Surgery
Zip code
Address
Kitakobayashi 880, Mibu-machi, Shimotoga-gun, Tochigi
TEL
0282-86-1111
Homepage URL
sumaeda-ths@umin.ac.jp
Sponsor or person
Institute
Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University and Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
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
Address
Tel
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
| 2016 | Year | 06 | Month | 13 | 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
336
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
| 2016 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Study design:Cohort study
Accrual period will start on 2016/06/13 and end either on 2018/06/30 or continue until 238 objects are enrolled.
Objectives are patients with spontaneous pneumothorax who are treated in the participating hospitals and express their consents to join this study.
Data collection: Height, weight, Age, smoking history, past history of pneumothorax, treatment courses, operative indications.
Management information
Registered date
| 2016 | Year | 06 | Month | 12 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024785
