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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019617
Receipt No. 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

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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
Email 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/
Email daisy_shuri@yahoo.co.jp

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.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


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