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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010034
Receipt No. 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

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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
Email 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
Email K-takemd@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba,Faculty of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011753

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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