UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030278 |
|---|---|
| Receipt number | R000034584 |
| Scientific Title | Prognostic impact of inflammatory-related biomarkers on the overall survival of patients with non-operable malignant pleural mesothelioma |
| Date of disclosure of the study information | 2017/12/07 |
| Last modified on | 2017/12/05 23:53:18 |
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Basic information
Public title
Prognostic impact of inflammatory-related biomarkers on the overall
survival of patients with non-operable malignant pleural mesothelioma
Acronym
Prognostic impact of inflammatory-related biomarkers on the overall
survival of patients with non-operable malignant pleural mesothelioma
Scientific Title
Prognostic impact of inflammatory-related biomarkers on the overall
survival of patients with non-operable malignant pleural mesothelioma
Scientific Title:Acronym
Prognostic impact of inflammatory-related biomarkers on the overall
survival of patients with non-operable malignant pleural mesothelioma
Region
| Japan |
Condition
Condition
malignant pleural mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aimed to assess the prognostic utilities of inflammatory-related biomarkers in non-operable MPM patients.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The medical records of consecutive patients with histologically confirmed malignant pleural mesothelioma (MPM) between January 2007 and August 2017 in our hospital were reviewed retrospectively.
Key exclusion criteria
MPM patients who received surgical treatment were excluded from this study. Patients who had active inflammatory disease (such as rheumatoid arthritis) or infection at the time of MPM diagnosis were excluded. Patients who were treated by chemotherapy or radiotherapy before the histological diagnosis of MPM, patients with MPM confirmed by autopsy, patients who had entered clinical trial study, patients with insufficient follow-up period (patients with follow-up period of less than one month after the diagnosis of MPM or patients who had received treatment at other hospitals after the diagnosis of MPM), were also excluded.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiro Otoshi |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo 660-8550, Japan
TEL
+81-(0)6-6480-7000
takehiro-otoshi19850902@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiro Otoshi |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo 660-8550, Japan
TEL
+81-(0)6-6480-7000
Homepage URL
takehiro-otoshi19850902@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Hyogo Prefectural Amagasaki General Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective observational study in a single center
Management information
Registered date
| 2017 | Year | 12 | Month | 06 | Day |
Last modified on
| 2017 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034584
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
