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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000020502 |
Receipt No. | R000023612 |
Scientific Title | Clinical study for evaluating serum/plasma biomarker levels of healthy subjects to compare with these of patients with lung diseases. |
Date of disclosure of the study information | 2016/02/01 |
Last modified on | 2016/04/26 |
Basic information | ||
Public title | Clinical study for evaluating serum/plasma biomarker levels of healthy subjects to compare with these of patients with lung diseases. | |
Acronym | Biomarkers in healthy subjects. | |
Scientific Title | Clinical study for evaluating serum/plasma biomarker levels of healthy subjects to compare with these of patients with lung diseases. | |
Scientific Title:Acronym | Biomarkers in healthy subjects. | |
Region |
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Condition | ||||
Condition | Healthy subjects | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare serum/plasma biomarker levels of healthy subjects to lung disease patients. |
Basic objectives2 | Others |
Basic objectives -Others | Explorative research for biomarkers. |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Others |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Biomarker levels |
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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Healthy subjects | |||
Key exclusion criteria |
Subjects who have no consent ability. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyorin University | ||||||
Division name | Department of respiratory medicine | ||||||
Zip code | |||||||
Address | 6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611 Japan | ||||||
TEL | 0422-47-5511 | ||||||
masato@ks.kyorin-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyorin University | ||||||
Division name | epartment of respiratory medicine | ||||||
Zip code | |||||||
Address | 6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611 Japan | ||||||
TEL | 0422-47-5511 | ||||||
Homepage URL | |||||||
masato@ks.kyorin-u.ac.jp |
Sponsor | |
Institute | Department of Respiratory Medicine, Kyorin University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Kosei Hospital, Nomura Hospital, Morimoto Hospital, Jiundoh Hospital, or Kurai Naika Clinic, who meet to our inclusion criteria, and who provide us a written informed consent.
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
Other related information | An observational study of healthy volunteers (case control study comparing to patients with respiratory disease).
We will obtain serum/plasma sample from donors (without respiratory diseases) who visit Kyorin University Hospital, Kousei Hospital, Nomura Hospital, Morimoto Hospital, Jiundoh Hospital, or Kurai Naika Clinic, Yasaka Kinen Hospital, who meet to our inclusion criteria, and who provide us a written informed consent. We will measure serum/plasma levels of biomarkers for lung diseases (i.e. IL-8, IL-6, sST2, LL-37, IL-33, carnitine, H2O2, and others). |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023612 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |