UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032117 |
|---|---|
| Receipt number | R000036640 |
| Scientific Title | A research that investigates the genetic factors for the idiopathic pulmonary pneumonias (IIPs) with the subjects that have been enrolled in the multi-institutional observational study for the IIPs, NEJ030. |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2022/04/15 16:14:39 |
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Basic information
Public title
A research that investigates the genetic factors for the idiopathic pulmonary pneumonias (IIPs) with the subjects that have been enrolled in the multi-institutional observational study for the IIPs, NEJ030.
Acronym
A study that investigates the genetic factors for the idiopathic pulmonary pneumonias, NEJ036A
Scientific Title
A research that investigates the genetic factors for the idiopathic pulmonary pneumonias (IIPs) with the subjects that have been enrolled in the multi-institutional observational study for the IIPs, NEJ030.
Scientific Title:Acronym
A study that investigates the genetic factors for the idiopathic pulmonary pneumonias, NEJ036A
Region
| Japan |
Condition
Condition
Idiopathic pulmonary pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of the current study is to investigate the biomarkers that may be associated in the idiopathic pulmonary pneumonias (IIPs). The biomarkers are investigated using blood samples, and include telomere length, the genetic polymorphisms/ mutations of the TERT, TERC, MUC5B, MUC4, TOLLIP, and SFTPA2 genes. A proceeding study, NEJ030, are collecting clinical information for each patient on the development, clinical course, classification, and response to drugs. The current study will investigate the association of the biomarkers investigated with the clinical factors collected in NEJ030.
Basic objectives2
Others
Basic objectives -Others
The blood samples and DNA collected will be banked in preparation of future studies for the novel biomarkers of IIPs.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The predictive value of the Telomere length, TERT, TERC, MUC5B, MUC4, TOLLIP, SFTPA2 polymorphisms/mutations for the development, clinical course, classification and response to drugs of idiopathic pulmonary pneumonias.
Key secondary outcomes
The association of the Telomere length, TERT, TERC, MUC5B, MUC4, TOLLIP, SFTPA2 polymorphisms/mutations for the development, clinical course, classification and response to drugs of idiopathic pulmonary pneumonias.
Bank the immortalized lymphocytes for the future studies that investigate the association of the development of IIPs with the novel genetic biomarkers.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Samples of the institution, of which institutional review board allowed to provide samples to an institution outside.
2) Samples taken from the patients who provided written informed consent.
3) Samples enrolled in the institution that participates in NEJ030 study. Samples collected in the Jichi Medical University is not allowed.
Key exclusion criteria
1) Samples taken from patients who is considered inappropriate for the inclusion by the responsible physician of each institution.
2) Samples taken from patients who refused to use their samples for the genetic analysis.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Hagiwara |
Organization
Jichi Medical University
Division name
Division of Pulmonary Medicine, Department of Internal Medicine
Zip code
329-0498
Address
3311-1 Shimotsuke-shi, Tochigi-ken 329-0498, Japan
TEL
+81-285-58-7349
hagiwark@me.com
Public contact
Name of contact person
| 1st name | Shu |
| Middle name | |
| Last name | Hisada |
Organization
Jichi Medical University
Division name
Division of Pulmonary Medicine, Department of Internal Medicine
Zip code
329-0498
Address
3311-1 Shimotsuke-shi, Tochigi-ken 329-0498, Japan
TEL
+81-48-778-9521
Homepage URL
http://www.nejsg.jp
hisata36@gmail.com
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
North East Japan Study Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University
Address
3311-1 Shimotsuke-shi, Tochigi-ken 329-0498, Japan
Tel
+81-285-58-8933
rksc_protocol@jichi.ac.jp
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
| 2018 | Year | 07 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
The biomarkers are investigated using blood samples, and include telomere length, the genetic polymorphisms/ mutations of the TERT, TERC, MUC5B, MUC4, TOLLIP, and SFTPA2 genes. A proceeding study, NEJ030, are collecting clinical information for each patient on the development, clinical course, classification, and response to drugs. The current study will investigate the association of the biomarkers investigated with the clinical factors collected in NEJ030.
Management information
Registered date
| 2018 | Year | 04 | Month | 05 | Day |
Last modified on
| 2022 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036640
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