UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019617 |
|---|---|
| Receipt number | R000022675 |
| Scientific Title | Prospective, multicenter study, detectation of HMGB1 under radiotherapy |
| Date of disclosure of the study information | 2015/11/03 |
| Last modified on | 2018/03/01 09:51:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective, multicenter study, detectation of HMGB1 under radiotherapy
Acronym
Detection of HMGB1 under radiotherapy
Scientific Title
Prospective, multicenter study, detectation of HMGB1 under radiotherapy
Scientific Title:Acronym
Detection of HMGB1 under radiotherapy
Region
| Japan |
Condition
Condition
lung cancer, esophageal cancer, mediastinal tomor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To detect the predictor for radiation pnuemonitis.
Basic objectives2
Others
Basic objectives -Others
obserbational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relation of radiation pneumonitis and HMGB1
Key secondary outcomes
Relation of severe radiation pneumonitis and HMGB1
Relation of overall survival and HMGB1
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
New patient of radiation to the chest malignant tumor.
Over 50Gy, BED>60Gy
Expectation 6 month survival
Informed consent
Key exclusion criteria
Interstitial pneumonitis and pulmonary fibrosis.
History of chest raiotherapy.
Preoperative radiotherapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Furui |
Organization
Teikyo University School of Medicine
Division name
Radiology
Zip code
Address
2-11-1 Kaga, Itabashi-ku Tokyo
TEL
+81-3-3964-1211
furui@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuri Aoki |
Organization
Teikyo University School of Medicine
Division name
Radiology
Zip code
Address
Kaga, Itabashi-ku, Tokyo
TEL
+81-3-3964-1211
Homepage URL
http://teikyohaigeka.com/
daisy_shuri@yahoo.co.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Teikyo University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shizuoka General Hospital
Nagahama City Hospital
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
帝京大学医学部附属病院（東京都）
静岡県立総合病院（静岡県）
私立長浜病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 03 | Day |
Related information
URL releasing protocol
http://teikyohaigeka.com/
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
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Selected patient
Management information
Registered date
| 2015 | Year | 11 | Month | 03 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022675
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
