UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027467 |
|---|---|
| Receipt number | R000031469 |
| Scientific Title | Research to validate the correlation of the quantitative fluorescence intensity with 5-aminolevulinic acid and malignancy index calculated with intra-operative rapid measurement of the amount of DNA in the tumors |
| Date of disclosure of the study information | 2017/05/23 |
| Last modified on | 2017/05/23 21:36:48 |
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Basic information
Public title
Research to validate the correlation of the quantitative fluorescence intensity with 5-aminolevulinic acid and malignancy index calculated with intra-operative rapid measurement of the amount of DNA in the tumors
Acronym
Research to validate the correlation of the quantitative fluorescence intensity with 5-aminolevulinic acid and malignancy index calculated with intra-operative rapid measurement of the amount of DNA in the tumors
Scientific Title
Research to validate the correlation of the quantitative fluorescence intensity with 5-aminolevulinic acid and malignancy index calculated with intra-operative rapid measurement of the amount of DNA in the tumors
Scientific Title:Acronym
Research to validate the correlation of the quantitative fluorescence intensity with 5-aminolevulinic acid and malignancy index calculated with intra-operative rapid measurement of the amount of DNA in the tumors
Region
| Japan |
Condition
Condition
malignant brain tumors
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the correlation fluorescence intensity of the brain tumors with 5-ALA and malignancy evaluated with the amount of DNA per single cells.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation of fluorescence radiance and the malignancy index calculated with the intraoperative rapid measurement of DNA per single cells.
Key secondary outcomes
Heterogeneity of malignancy calculated with the intraoperative rapid measurement of intracellular amount of DNA in the weak fluorescent area.
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
Patients planed fluorescence guided surgery with 5-ALA
Key exclusion criteria
i) the patients with hypersensitivity for 5-ALA
ii) the patients with a history of porphyria
iii) the patients with severe liver disfunction
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Kuroiwa |
Organization
Osaka Medical College
Division name
Department of Neurosurgery and Endovascular Neurosurgery
Zip code
Address
2-7 Daigaku-Machi, Takatsuki, Osaka, Japan
TEL
+81-72-683-1221
neu040@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naokado Ikeda |
Organization
Osaka Medical College
Division name
Department of Neurosurgery and Endovascular Neurosurgery
Zip code
Address
2-7 Daigaku-Machi, Takatsuki, Osaka, Japan
TEL
+81-72-683-1221
Homepage URL
neu098@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
self-sustaining fund
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
大阪医科大学附属病院 (大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
With the remaining specimen,
*measurement of the quantitative fluorescence intra-operative rapid measurement of the amount of
*the intra-cellular DNA
*assessment of malignancy with HE and immunohisto
-chemical stained specimens
Management information
Registered date
| 2017 | Year | 05 | Month | 23 | Day |
Last modified on
| 2017 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031469
