UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010034 |
|---|---|
| Receipt number | R000011753 |
| Scientific Title | Genetic testing for Hereditary pheochromocytoma/ paraganglioma syndrome(HPPS) |
| Date of disclosure of the study information | 2013/02/15 |
| Last modified on | 2014/09/25 13:47:41 |
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Basic information
Public title
Genetic testing for Hereditary pheochromocytoma/ paraganglioma syndrome(HPPS)
Acronym
Evaluation of genetic testing for HPPS
Scientific Title
Genetic testing for Hereditary pheochromocytoma/ paraganglioma syndrome(HPPS)
Scientific Title:Acronym
Evaluation of genetic testing for HPPS
Region
| Japan |
Condition
Condition
Pheochromocytoma and Paraganglioma
Index case
Asymptomatic carrier(first relative degrees)
Classification by specialty
| Endocrinology and Metabolism | Endocrine surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluate genetic testing for Hereditary pheochromocytoma/ paraganglioma syndrome in Japan.
Available genes are as follows :
SDHB
SDHD
TMEM127
MAX
RET
VHL
MLPA(SDHB, SDHD, SDHA, SDHC, SDHAF2)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficasy for genetic testing for HPPS
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Index case of HPPS, especially, paraganglioma(extra adrenal)and/or younger than 30years old, malignancy, recurrence, bilatelal,familial.
Asymptomatic carrier (first relative degrees )
Key exclusion criteria
under 16 years old
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Takekoshi, M.D., Ph.D. |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
Tennoudai 1-1-1, Tsukuba city
TEL
029-853-3389
K-takemd@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Takekoshi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
Tenoudai 1-1-1 Tsukuba city
TEL
029-853-3389
Homepage URL
http://www.trios.tsukuba.ac.jp/Profiles/0009/0001225/profile.html
K-takemd@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba,Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
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
信州大学医学部
東京女子医科大学
関西医科大学
名古屋大学医学部
浜松医大
日本医科大学
東北大学医学部
慶応義塾大学医学部
佐賀大学医学部
産業医大
福島県立医大
大阪大学医学部
京都大学医学部
群馬大学医学部
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 15 | 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
Takeichi N,et al .Identical Germline Mutations in the TMEM127 Gene in 2 Unrelated Japanese Patients with Bilateral Pheochromocytoma. Clinical Endocrinology,77,7.7-714,2012
Kodama H, Iihara M, Nissato S, Isobe K, Kawakami Y, Okamoto T, Takekoshi K: A large deletion in the succinate dehydrogenase B gene (SDHB) in a Japanese patient with abdominal paraganglioma and concomitant metastasis. Endocrine Journal, 57, 351-356, 2010
Saito T, Saito Y, Matsumura K, Tsubota Y, Maniwa T, Kaneda H, Minami K, Sakaida N, Uemura Y, Kawa G, Yamamoto N, Fujii Y, Isobe K, Kawakami Y, Matsuda T, Takekoshi K: Novel mutation (L157X) in the succinate dehydrogenase B gene (SDHB) in a Japanese family with abdominal paraganglioma following lung metastasis. Endocrine Journal, 56, 451-458, 2009
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
Open public recruiting
Date of protocol fixation
| 2007 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obervation of prognosis
Management information
Registered date
| 2013 | Year | 02 | Month | 14 | Day |
Last modified on
| 2014 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011753
