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

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 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


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

Value
https://center6.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