UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002471 |
|---|---|
| Receipt number | R000003028 |
| Scientific Title | The study of specific protein markers in pineal parenchymal tumors |
| Date of disclosure of the study information | 2009/09/08 |
| Last modified on | 2019/03/18 06:56:21 |
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Basic information
Public title
The study of specific protein markers in pineal parenchymal tumors
Acronym
Pineal parenchymal tumors
Scientific Title
The study of specific protein markers in pineal parenchymal tumors
Scientific Title:Acronym
Pineal parenchymal tumors
Region
| Japan |
Condition
Condition
Pineal parenchymal cell tumors
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We analyze pineal parenchymal tumors and embryonal tumors in CNS by immunohistochemistry for evidence of melatonin synthesis.
Basic objectives2
Others
Basic objectives -Others
We will make the antibody against hydroxyindol-O-methyltransferase (HIOMT) and analyze normal pineal glands and the other human organs by immunohistochemistry for evidence of melatonin synthesis. We will further analyze the correlation of the expression of HIOMT with the histological differentiation of PPTs.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Control tissue, consisting of cerebrum, cerebellum, brain stem, spinal cord, dorsal root ganglion, pineal gland, pituitary gland, thyroid gland, parathyroid gland, adrenal gland, lung, heart, liver, spleen, pancreas, stomach, duodenum, small intestine, colon, kidney, prostate, testis, ovary, and bone marrow, was obtained from patients without neurologic disease and without pathologic abnormalities. Tumor specimens consisted of 8 PPTs (one PC, four PPTIDs, three PB), 3 central nervous system primitive neuroectodermal tumors (PNET), and 8 medulloblastomas (MB). We analyze normal pineal glands, the other human organs, PPTs, and embryonal tumors in CNS by immunohistochemistry for evidence of melatonin synthesis. We further analyse the correlation of the expression of HIOMT with the histological differentiation of PPTs.
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
| 0 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The cases of pineal parenchymal tumor
The cases of PNET
The cases of medulloblastoma
The cases without neurologic disease and without pathologic abnormalities
Key exclusion criteria
The cases with neurologic disease and without pathologic abnormalities
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Fukuda |
Organization
Research Center for Medical Science, The Jikei University School of Medicine
Division name
Division of Neuropathology, Department of Neurosciences
Zip code
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Fukuda |
Organization
Research Center for Medical Science, The Jikei University School of Medicine
Division name
Division of Neuropathology, Department of Neurosciences
Zip code
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
fukuda-t@jikei.ac.jp
Sponsor or person
Institute
Division of Neuropathology, Department of Neurosciences, Research Center for Medical Science, The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Neuropathology, Department of Neurosciences, Research Center for Medical Science, The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
20-201 5491
Org. issuing International ID_1
The Jikei University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京慈恵会医科大学
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In human tissue, HIOMT was expressed in retinal cells, pineal parenchymal cells, neurons of the Edinger-Westphal nucleus, microglia, macrophages, thyroid follicular epithelium, principal and oxyphil cells of parathyroid gland, adrenal cortical cells, hepatic parenchymal cells, renal tubule epithelial cells, and enteroendocrine cells of stomach and duodenum. HIOMT was expressed in all PPTs studied. The ratio of HIOMT-immunoreactive cells successively decreased in the following tumors: pineocytoma, pineocytomatous area of PPTIDs, PPTID, pineoblastomatous area of PPTIDs, and pineoblastoma. In one of three PNETs and four of eight MBs, a few HIOMT-immunoreactive cells were observed. HIOMT immunohistochemistry is useful in diagnosing PPTs and may be one of the predictive factors affecting the survival of PPTs.
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
| 2009 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sampling by case control
Management information
Registered date
| 2009 | Year | 09 | Month | 08 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003028
