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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016794
Receipt No. R000019494
Scientific Title Phase II trial of treatment based on gene profiling diagnosis using next generation sequencing for carcinoma of unknown primary site
Date of disclosure of the study information 2015/03/13
Last modified on 2015/03/13

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Basic information
Public title Phase II trial of treatment based on gene profiling diagnosis using next generation sequencing for carcinoma of unknown primary site
Acronym Phase II trial of treatment strategy using NGS for carcinoma of unknown primary
Scientific Title Phase II trial of treatment based on gene profiling diagnosis using next generation sequencing for carcinoma of unknown primary site
Scientific Title:Acronym Phase II trial of treatment strategy using NGS for carcinoma of unknown primary
Region
Japan

Condition
Condition Untreated Carcinoma of Unknown Primary Site
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the utility of the next generation sequencing assay in identifying the tissue of origin in patients with carcinoma of unknown primary site.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes One year overall survival rate
Key secondary outcomes Overall survival, Progression free survival, response rate, safety, exploratory anarysis association between results of gene profiling and efficacy,
Frequency of gene mutation/amplification

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 Treatment strategy using next generation sequencing
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients must have biopsy-proven metastatic carcinoma
(2)No previous treatment with any systemic therapy.
(3)Patients must have biopsy material available to provide an adequate specimen for the gene profiling assay.
(4)Age, over 20 years old.
(5)An ECOG performance status 0, 1, or 2.
(6)Laboratory values as follows:
WBC 4000/micro L,
Platelets 100,000/micro L,
Serum AST/ALT <100 IU/L
Serum bilirubin <1.5 mg/dl
Serum creatinine < 1.5 mg/dL.
Key exclusion criteria (1)Patients with the specific sub groups are not eligible:
(2)Patients with uncontrolled brain metastases and all patients with meningeal metastases.
(3)Women who are pregnant or lactating.
drug within 28 days of starting treatment
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Nakagawa
Organization Kinki University, Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2, Ohnohigashi, Osaka-sayama city, Osaka
TEL 072-366-0221
Email nakagawa@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidetoshi Hayashi
Organization Kishiwada City Hospital
Division name Department of Medical Oncology
Zip code
Address 1001 Gakuharacho, Kishiwada, Osaka
TEL 072-445-1000
Homepage URL
Email hidet31@gmail.com

Sponsor
Institute Ministry of Health, Labour and Welfare scientific research Nakagawa squad
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 近畿大学医学部附属病院
市立岸和田市民病院
関西医科大学付属枚方病院
和歌山県立医科大学付属病院
千葉大学医学部附属病院 
静岡県立静岡がんセンター
虎の門病院
東北大学 
栃木県立がんセンター
大阪市立総合医療センター 
兵庫県立がんセンター
神戸大学医学部付属病院
埼玉医科大学国際医療センター
国立がん研究センター東病院 
岐阜市民病院 
がん研究会有明病院

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 13 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
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 Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 13 Day
Last modified on
2015 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019494

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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