UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002018
Receipt number R000002461
Scientific Title Prospective study of correlation between prognosis and quantitative detection of circulating tumor cell (CTC) in peripheral blood from patients with gastric cancer
Date of disclosure of the study information 2009/05/29
Last modified on 2016/12/04 09:58:42

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Basic information

Public title

Prospective study of correlation between prognosis and quantitative detection of circulating tumor cell (CTC) in peripheral blood from patients with gastric cancer

Acronym

Prognosis and quantitative detection of circulating tumor cell (CTC) in blood from patients with gastric cancer

Scientific Title

Prospective study of correlation between prognosis and quantitative detection of circulating tumor cell (CTC) in peripheral blood from patients with gastric cancer

Scientific Title:Acronym

Prognosis and quantitative detection of circulating tumor cell (CTC) in blood from patients with gastric cancer

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We will evaluate correlation between prognosis and quantitative detection of circulating tumor cell (CTC) in blood from patients with gastric cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

measured value of circulating tumor cell (CTC)in peripheral blood, overall survival and relapse-free survival

Key secondary outcomes

Tumor clinical factor, tumor pathological factor and patients background


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Measurement of circulating tumor cell (CTC) in peripheral blood from patients with gastric cancer

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Gastric cancer patient
Informed consent

Key exclusion criteria

Association of malignant neoplasms of other organs

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Ito, MD, PhD

Organization

Showa University Nothern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.

TEL

045-949-7000

Email

h.ito@med.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Ito, MD, PhD

Organization

Showa University Nothern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.

TEL

045-949-7000

Homepage URL


Email

h.ito@med.showa-u.ac.jp


Sponsor or person

Institute

Digestive Disease Center, Showa University Nothern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

Digestive Disease Center, Showa University Nothern Yokohama Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

SYSMEX CORPORATION

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

2009 Year 05 Month 29 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2009 Year 04 Month 22 Day

Date of IRB


Anticipated trial start date

2009 Year 09 Month 01 Day

Last follow-up date

2015 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 05 Month 29 Day

Last modified on

2016 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002461


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name