UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016794 |
|---|---|
| Receipt number | 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 | 2022/03/18 12:46:27 |
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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
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
hidet31@gmail.com
Sponsor or person
Institute
Ministry of Health, Labour and Welfare scientific research Nakagawa squad
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
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
| 2022 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019494
