UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study to clarify the pathology of malignant tumors using cancer clinical sequence data and to evaluate the clinical value of cancer clinical sequence
Title of the study (Brief title)	Observational study for evaluation of basic and clinical value of cancer clinical sequence
Region	Japan

Condition
Condition	Patients who underwent cancer clinical sequence examination
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate and clarify the effect of cancer clinical sequence on treatment and prognosis of cancer patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prognosis of patients who underwent cancer clinical sequence
Key secondary outcomes	Whether the cancer clinical sequence had influence on patient's treatment choice

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	subjects who obtained document agreement with the free will of the subjects themselves or substitute persons with sufficient understanding, after receiving sufficient explanation for participation in this research
Key exclusion criteria	Patients who are judged inappropriate as the subject by the research director
Target sample size	1000

Research contact person
Name of lead principal investigator	Shunsuke Kato
Organization	Juntendo Univ Hospital
Division name	Dept Oncology
Address	3-1-3 Hongo Bunkyo Tokyo, Japan
TEL	03-3813-3111
Email	katoshun@juntendo.ac.jp

Public contact
Name of contact person	Shunsuke Kato
Organization	Juntendo Univ Hospital
Division name	Dept Oncology
Address	3-1-3 Hongo Bunkyo Tokyo, Japan
TEL	03-3813-3111
Homepage URL
Email	katoshun@juntendo.ac.jp

Sponsor
Institute	Juntendo Univ Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Secondary IDs
Secondary IDs	YES
Study ID_1	2016044
Org. issuing International ID_1	Juntendo Univ Hospital
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 11 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 01 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date
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	It is a collaborative research with the Yokohama City University hospital

Management information
Registered date	2017 Year 10 Month 30 Day
Last modified on	2017 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034007