UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007067
Receipt number R000008325
Scientific Title Detection of circulating tumor cells in lung cancer
Date of disclosure of the study information 2012/01/16
Last modified on 2012/01/13 20:46:13

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Basic information

Public title

Detection of circulating tumor cells in lung cancer

Acronym

Detection of circulating tumor cells in lung cancer

Scientific Title

Detection of circulating tumor cells in lung cancer

Scientific Title:Acronym

Detection of circulating tumor cells in lung cancer

Region

Japan


Condition

Condition

Primary lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Detection of circulating tumor cells (CTCs) in peripheral blood and bone marrow in primary lung cancer

Basic objectives2

Others

Basic objectives -Others

Correlation between CTC detection and clinical and pathological stage

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection rate of CTC

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

pathlogically proven lung cancer

Key exclusion criteria

none

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yotaro Izumi

Organization

School of Medicine, Keio University

Division name

General Thoracic Surgery

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-1211

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

School of Medicine, Keio University

Division name

General Thoracic Surgery

Zip code


Address


TEL


Homepage URL


Email

keiothoracicsurg@gmail.com


Sponsor or person

Institute

General Thoracic Surgery, School of Medicine, Keio University

Institute

Department

Personal name



Funding Source

Organization

General Thoracic Surgery, School of Medicine, Keio University

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

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

2012 Year 01 Month 16 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

2012 Year 01 Month 13 Day

Date of IRB


Anticipated trial start date

2012 Year 01 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

Detection of CTC in peripheral blood (10 ml) and/or bone marrow aspirate (2 ml). A prospective evaluation.


Management information

Registered date

2012 Year 01 Month 13 Day

Last modified on

2012 Year 01 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008325


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name