UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005652 |
|---|---|
| Receipt number | R000006679 |
| Scientific Title | Development of a new carcinomatous pleural effusion/ascites screening laboratory procedure based on the measurement of protoporphyrins. |
| Date of disclosure of the study information | 2011/05/30 |
| Last modified on | 2015/05/28 21:06:36 |
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Basic information
Public title
Development of a new carcinomatous pleural effusion/ascites screening laboratory procedure based on the measurement of protoporphyrins.
Acronym
Development of new examination for carcinomatous pleural effusion and ascites
Scientific Title
Development of a new carcinomatous pleural effusion/ascites screening laboratory procedure based on the measurement of protoporphyrins.
Scientific Title:Acronym
Development of new examination for carcinomatous pleural effusion and ascites
Region
| Japan |
Condition
Condition
carcinomatous pleural effusion and carcinomatous ascites
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is examined whether the measurement of PPIX in pleural effusion and the ascites fluid is useful for the diagnosis of cancaer.
Basic objectives2
Others
Basic objectives -Others
laboratory procedure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ROC curve and t test.
Protoporphyrins in fluid samples are measured in carcinomatous pleural effusion, carcinomatous ascites and the control.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases who have pleural effusion or ascites fluid
Key exclusion criteria
none
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Yamamoto |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
Address
1-8-13 Kanda-Surugadai Chiyoda-ku, Tokyo
TEL
03-3293-1711
yamamoto.toshiki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiki Yamamoto |
Organization
Surugadai Nihon University Hospital
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
Address
1-8-13 Kanda-Surugada Chiyoda-ku, Tokyo
TEL
03-3293-1711
Homepage URL
yamamoto.toshiki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology and Hepatology, Department of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 05 | Month | 30 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 30 | Day |
Other
Other related information
Protoporphyrins are measured by the HPLC and the fluorometrical method.
Management information
Registered date
| 2011 | Year | 05 | Month | 26 | Day |
Last modified on
| 2015 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006679
