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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024455
Receipt No. R000028149
Scientific Title The Utility of Hyperacetylated HMGB1 as Tumor Marker of Malignant Mesothelioma; a prospective observational study
Date of disclosure of the study information 2016/11/01
Last modified on 2018/04/20

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Basic information
Public title The Utility of Hyperacetylated HMGB1 as Tumor Marker of Malignant Mesothelioma; a prospective observational study
Acronym The Utility of Hyperacetylated HMGB1 as Tumor Marker of Malignant Mesothelioma
Scientific Title The Utility of Hyperacetylated HMGB1 as Tumor Marker of Malignant Mesothelioma; a prospective observational study
Scientific Title:Acronym The Utility of Hyperacetylated HMGB1 as Tumor Marker of Malignant Mesothelioma
Region
Japan North America

Condition
Condition Malignant Mesothelioma
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the utility of total HMGB1 and its isoforms ( redox and/or acetylated) as biomarkers of malignant mesothelioma
Basic objectives2 Others
Basic objectives -Others To assess the ability of HMGB1 for a prognostic prediction
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ability of prognostic prediction and correlations with IMIG classification, existing tumor markers, and inflammatory factors of HMGB1 and its isoforms
Key secondary outcomes Ability of prognosis prediction, correlations with IMIG classification, existing tumor markers, and inflammatory factors

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Pathologically diagnosed malignant mesothelioma patients.
2. Patients with pleural effusion, which is derived from malignant tumor other than malignant mesothelioma.
3. Patients with benign pleural effusion
4. Healthy volunteers
Key exclusion criteria 1. Patients who refuse to participate in the study
2. Any patient found to be not applicable by an examiner
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Shinkai
Organization Yokohama City University Graduate School of Medicine
Division name Department of Pulmonology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2508
Email shinkai@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryota Ushio / Masaharu Shinkai
Organization Yokohama City University Graduate School of Medicine
Division name Department of Pulmonology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2508
Homepage URL
Email rushio@yokohama-cu.ac.jp

Sponsor
Institute Department of Pulmonology, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor University of Hawaii Cancer Center, Thoracic Oncology Program
Name of secondary funder(s)

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 横浜市立大学医学部 (神奈川県)
横浜市立大学附属病院 (神奈川県)
横浜市立大学附属市民総合医療センター (神奈川県)
藤沢市民病院 (神奈川県)
済生会横浜市南部病院 (神奈川県)
横浜南共済病院 (神奈川県)
横浜栄共済病院 (神奈川県)
国立病院横浜医療センター (神奈川県)
大和市立病院 (神奈川県)
茅ヶ崎市立病院 (神奈川県)
関東労災病院 (神奈川県)
横浜労災病院 (神奈川県)
横須賀市立市民病院 (神奈川県)
神奈川県立がんセンター (神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Objective: Patients who visit our institution from November 1st, 2016 to August 31st, 2019, and who meet the inclusion criterion.
Observation parameters: Medical history, IMIG grade of malignant mesothelioma, complications, levels of inflammatory and existing tumor markers in blood, pathological and bacteriological diagnosis of pleural effusion, levels of inflammatory factors in pleural effusion.

Management information
Registered date
2016 Year 10 Month 18 Day
Last modified on
2018 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028149

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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