UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024455 |
|---|---|
| Receipt number | 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 23:08:55 |
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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
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
rushio@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Pulmonology, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028149
