UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029764
Receipt number R000034007
Scientific Title Observational study to clarify the pathology of malignant tumors using cancer clinical sequence data and to evaluate the clinical value of cancer clinical sequence
Date of disclosure of the study information 2017/11/01
Last modified on 2017/11/01 09:00:07

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Basic information

Public title

Observational study to clarify the pathology of malignant tumors using cancer clinical sequence data and to evaluate the clinical value of cancer clinical sequence

Acronym

Observational study for evaluation of basic and clinical value of cancer clinical sequence

Scientific Title

Observational study to clarify the pathology of malignant tumors using cancer clinical sequence data and to evaluate the clinical value of cancer clinical sequence

Scientific Title:Acronym

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

1st name
Middle name
Last name Shunsuke Kato

Organization

Juntendo Univ Hospital

Division name

Dept Oncology

Zip code


Address

3-1-3 Hongo Bunkyo Tokyo, Japan

TEL

03-3813-3111

Email

katoshun@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Kato

Organization

Juntendo Univ Hospital

Division name

Dept Oncology

Zip code


Address

3-1-3 Hongo Bunkyo Tokyo, Japan

TEL

03-3813-3111

Homepage URL


Email

katoshun@juntendo.ac.jp


Sponsor or person

Institute

Juntendo Univ Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Open public recruiting

Date of protocol fixation

2017 Year 11 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034007


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name