UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Precision Cancer Medicine Registration Study of Omics Data from Genomic Information Analysis Leading to New Effective Therapy
Title of the study (Brief title)	PROFILE study
Region	Japan

Condition
Condition	a) any cancer that becomes refractory/intolerant to standard therapy b) cancer of unknown primary c) rare malignancy
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	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.
Basic objectives2	Others
Basic objectives -Others	The goal of this study is to registor real-world data and utilize big data to develop novel biomarker or therapeutics.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	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.)
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	1 years-old <=
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	a) any cancer or malignancy that becomes refractory/intolerant to standard thearpy b) cancer of unknown origin c) rare cancer
Key exclusion criteria	- those who cannot consent
Target sample size	500

Research contact person
Name of lead principal investigator	Sadakatsu Ikeda
Organization	Tokyo Medical and Dental University
Division name	Cancer Center
Address	1-5-45 Yushima, Bunkyo, Tokyo, Japan
TEL	03-5803-4873
Email	ikeda.canc@tmd.ac.jp

Public contact
Name of contact person	Junko Yokobori
Organization	Tokyo Medical and Dental University
Division name	Cancer Center
Address	1-5-45 Yushima, Bunkyo, Tokyo, Japan
TEL	03-5803-4873
Homepage URL
Email	j.yokobori.mnrs@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University Cancer Center
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 22 Day
Anticipated trial start date	2017 Year 07 Month 19 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2017 Year 07 Month 29 Day
Last modified on	2018 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032555