UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022626 |
|---|---|
| Receipt number | 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 09:51:28 |
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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
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
tsato@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Japanese Association for Chest Surgery
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
