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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000027844 |
Receipt No. | R000031899 |
Scientific Title | Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2020/06/13 |
Basic information | ||
Public title | Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria | |
Acronym | Prospective observational study of acute exacerbation in interstitial lung diseases (AEILD Study) | |
Scientific Title | Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria | |
Scientific Title:Acronym | Prospective observational study of acute exacerbation in interstitial lung diseases (AEILD Study) | |
Region |
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Condition | ||
Condition | acute deterioration of interstitial lung diseases | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To clarify the relationship between prognosis and clinical factors in interstitial lung diseases after the deterioration of dyspnea with new pulmonary shadows |
Basic objectives2 | Others |
Basic objectives -Others | To make new diagnostic criteria of acute exacerbation of interstitial lung diseases |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Clinical factors to determine 3-month survival of acute deterioration in interstitial lung diseases |
Key secondary outcomes | 1)Clinical factors to determine 1-year survival of acute deterioration in interstitial lung diseases
2)Change of clinical parameters after acute deterioration of ILDs 3)Therapy 4)Cause of death 5)Adverse events 6)Efficacy of present diagnostic criteria of acute exacerbation 7)Comparison of present diagnostic criterion of acute exacerbation 8)To make a new diagnostic criteria of acute exacerbation of ILDs |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) idiopathic interstitial pneumonias (IIPs) and interstitial lung diseases (ILDs) other than IIPs including chronic hypersensitivity pneumonia, collagen vascular diseases-ILDs and asbestosis
2) Cases that deteriorated with deterioration of dyspnea and newly developed pulmonary shadows. |
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Key exclusion criteria | 1) Survival is supposed to be less than 3 months due to complications of ILDs
2) Cases that researchers have determined to be improper for inclusion |
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Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | NHO Kinki-Chuo Chest Medical Center | ||||||
Division name | Clinical Research Center | ||||||
Zip code | 591-8555 | ||||||
Address | 1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan | ||||||
TEL | 072-252-3021 | ||||||
arai.toru.cp@mail.hosp.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | NHO Kinki-Chuo Chest Medical Center | ||||||
Division name | Clinical Research Center | ||||||
Zip code | 591-8555 | ||||||
Address | 1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan | ||||||
TEL | 072-252-3021 | ||||||
Homepage URL | |||||||
matsui.yuki.yx@mail.hosp.go.jp |
Sponsor | |
Institute | National Hospital Organization Kinki-Chuo Chest Medical Center |
Institute | |
Department |
Funding Source | |
Organization | National Hospital Organization |
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 | Review board of NHO Kinki-Chuo Chest Medical Center |
Address | 1180 Nagasone-Cho, Kita-Ku, Sakai Osaka, Japan |
Tel | 072-252-3021 |
agata.yuka.zd@mail.hosp.go.jp |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | H28-NHO(Kokyu)-02 |
Org. issuing International ID_1 | National Hospital Organization |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 416 |
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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Birth month, gender, past history, complications, smoking status, height, weight, physical examination, radiological findings, laboratory findings, therapy, clinical course, outcome, last follow-up date |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031899 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |