Unique ID issued by UMIN | UMIN000028439 |
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Receipt number | R000032555 |
Scientific Title | Precision Cancer Medicine Registration Study of Omics Data from Genomic Information Analysis Leading to New Effective Therapy |
Date of disclosure of the study information | 2017/10/01 |
Last modified on | 2018/08/08 14:38:15 |
Precision Cancer Medicine Registration Study of Omics Data from Genomic Information Analysis Leading to New Effective Therapy
PROFILE study
Precision Cancer Medicine Registration Study of Omics Data from Genomic Information Analysis Leading to New Effective Therapy
PROFILE study
Japan |
a) any cancer that becomes refractory/intolerant to standard therapy
b) cancer of unknown primary
c) rare malignancy
Hematology and clinical oncology |
Malignancy
YES
The purpose of this registrative study is to identify actionable genomic alterations by genomic sequencing and build the registry that could be used for generating real-world evidence.
Others
The goal of this study is to registor real-world data and utilize big data to develop novel biomarker or therapeutics.
Exploratory
Not applicable
The following items will be recorded in the registry.
a. Demographic (age, sex, co-morbidities, family history, social history)
b. Diagnosis (tumor type, histology, primary site, metastatic site, stage)
c. Treatment (modality, regimen, response, duration of response, adverse event, QOL)
d. Genomic alteration (method, QC, gene name, alteration type, details of alteration etc.)
e. Outcome (overall survival, disease-free survival, progression-free survival, relapse-free survival etc.)
Observational
1 | years-old | <= |
120 | years-old | >= |
Male and Female
a) any cancer or malignancy that becomes refractory/intolerant to standard thearpy
b) cancer of unknown origin
c) rare cancer
- those who cannot consent
500
1st name | |
Middle name | |
Last name | Sadakatsu Ikeda |
Tokyo Medical and Dental University
Cancer Center
1-5-45 Yushima, Bunkyo, Tokyo, Japan
03-5803-4873
ikeda.canc@tmd.ac.jp
1st name | |
Middle name | |
Last name | Junko Yokobori |
Tokyo Medical and Dental University
Cancer Center
1-5-45 Yushima, Bunkyo, Tokyo, Japan
03-5803-4873
j.yokobori.mnrs@tmd.ac.jp
Tokyo Medical and Dental University
Cancer Center
AMED
Japanese Governmental office
NO
2017 | Year | 10 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 06 | Month | 22 | Day |
2017 | Year | 07 | Month | 19 | Day |
2022 | Year | 03 | Month | 31 | Day |
none
2017 | Year | 07 | Month | 29 | Day |
2018 | Year | 08 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032555
Research Plan | |
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Registered date | File name |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |