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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002471
Receipt No. 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

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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
Email

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
Email fukuda-t@jikei.ac.jp

Sponsor
Institute Division of Neuropathology, Department of Neurosciences, Research Center for Medical Science, The Jikei University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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