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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
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 | 2022/03/18 |
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 |
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Condition | |||
Condition | Untreated Carcinoma of Unknown Primary Site | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 110 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.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 |