UMIN-CTR Clinical Trial
| 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 (Ver. 3) |
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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 |
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| Condition | ||
| Condition | Pineal parenchymal cell tumors | |
| Classification by specialty |
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| 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 | |
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| Randomization | |
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| Blinding | |
| Control | |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
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| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| Key exclusion criteria | The cases with neurologic disease and without pathologic abnormalities | |||
| Target sample size | 80 | |||
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| Last name of lead principal investigator |
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| 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 | ||||||
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| 1st name of contact person |
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| 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 | |
| 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 |
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| 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 | |
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| IND to MHLW | |
| Institutions | |
| Institutions | 東京慈恵会医科大学 |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Partially published |
| Result | |
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| 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. |
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| Recruitment status | Completed | ||||||
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| Other | |
| Other related information | Sampling by case control |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003028 |
