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 2022/12/20 21:49:51

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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


Email



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


Date trial data considered complete


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

2022 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024785


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name