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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022626
Receipt No. R000026064
Scientific Title Risk Evaluation of Acute Exacerbation After pulmonary resection in Lung Cancer Patients with Interstitial Pneumonia (REVEAL-IP)
Date of disclosure of the study information 2016/06/06
Last modified on 2018/12/08

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Basic information
Public title Risk Evaluation of Acute Exacerbation After pulmonary resection in Lung Cancer Patients with Interstitial Pneumonia
(REVEAL-IP)
Acronym A validation of risk score system predicting post-operative acute exacerbation of interstitial pneumonia.
Scientific Title Risk Evaluation of Acute Exacerbation After pulmonary resection in Lung Cancer Patients with Interstitial Pneumonia
(REVEAL-IP)
Scientific Title:Acronym A validation of risk score system predicting post-operative acute exacerbation of interstitial pneumonia.
Region
Japan

Condition
Condition Lung cancer
Interstitial pneumonia
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 JACS (Japanese Association for Chest Surgery) had conducted multicenter retrospective analysis of the surgical treatment for the lung cancer patients with interstitial lung disease, and identified 7 risk factors for post-operative acute exacerbation as follows; sex (male), surgical procedures, UIP pattern in CT scan, steroid use, history of acute exacerbation in the past, high serum level of KL-6, low %VC.
Based on these observations, JACS also proposing a risk score which predicts the risk of post-operative acute exacerbation of interstitial lung disease.
Basic objectives2 Others
Basic objectives -Others A prospective validation study to evaluate the proposed risk score system.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Incident of acute-exacerbation during 30 days after pulmonary resection of lung cancer
Key secondary outcomes Prognosis
Cause of death

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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Small cell lung cancer patients with interstitial lung disease who are intended to have pulmonary resection.
(2) Diagnosis of ILDs should be confirmed based on a combination of clinical and radiologic findings according to the clinical criteria proposed by the Japanese Respiratory Society, which are consistent with the guidelines of the American Thoracic Society in 2013. The cases are subjected to be categorized into 3 groups, according to their radiological appearance: 1. UIP, 2. Possible UIP, 3. Inconsistent with UIP pattern.
Key exclusion criteria This is a prospective observational, non-invasive study. Exclusion criteria is not defined in order to guarantee the external validity of the findings, and to be a comprehensive registration and informations gathering.
Target sample size 1250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Date
Organization Kyoto University Hospital
Division name Thoracic Surgery
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-254-0545
Email hdate@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Sato
Organization Kyoto University Hospital
Division name Thpracic surgery
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-4975
Homepage URL
Email tsato@kuhp.kyoto-u.ac.jp

Sponsor
Institute Japanese Association for Chest Surgery
Institute
Department

Funding Source
Organization Japanese Association for Chest Surgery
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 R0542
Org. issuing International ID_1 Kyoto University Hospital
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 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
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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
2019 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective Multicenter Cohort Study.
Our porpose is proposing and evaluating a risk score which predicts the risk of post-operative acute exacerbation of interstitial lung disease.

Management information
Registered date
2016 Year 06 Month 06 Day
Last modified on
2018 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026064

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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