UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028439
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

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Basic information

Public title

Precision Cancer Medicine Registration Study of Omics Data from Genomic Information Analysis Leading to New Effective Therapy

Acronym

PROFILE study

Scientific Title

Precision Cancer Medicine Registration Study of Omics Data from Genomic Information Analysis Leading to New Effective Therapy

Scientific Title:Acronym

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

1st name
Middle name
Last name Sadakatsu Ikeda

Organization

Tokyo Medical and Dental University

Division name

Cancer Center

Zip code


Address

1-5-45 Yushima, Bunkyo, Tokyo, Japan

TEL

03-5803-4873

Email

ikeda.canc@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junko Yokobori

Organization

Tokyo Medical and Dental University

Division name

Cancer Center

Zip code


Address

1-5-45 Yushima, Bunkyo, Tokyo, Japan

TEL

03-5803-4873

Homepage URL


Email

j.yokobori.mnrs@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University
Cancer Center

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 01 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

2017 Year 06 Month 22 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032555


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name