UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009818
Receipt number R000011505
Scientific Title Development of rapid detection methods on cancer-related antigen in blood serum samples from gastric and colon cancer patients
Date of disclosure of the study information 2013/01/20
Last modified on 2016/04/15 09:16:00

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Basic information

Public title

Development of rapid detection methods on cancer-related antigen in blood serum samples from gastric and colon cancer patients

Acronym

Rapid detection methods on gastric and colon cancer-related antigen in blood serum samples

Scientific Title

Development of rapid detection methods on cancer-related antigen in blood serum samples from gastric and colon cancer patients

Scientific Title:Acronym

Rapid detection methods on gastric and colon cancer-related antigen in blood serum samples

Region

Japan


Condition

Condition

Gastric cancer and colon cancer

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Laboratory medicine Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Development of rapid detection methods on cancer-related antigen in blood serum from patients with digestive tract cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection of cancer-related antigen.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) patients with histologically proven gastric and colon cancer. And benign disease patients without cancer.
(2) clinical solitary tumor
(3) no prior treatment
(4) age 20-80 years
(5) Eastern Cooperative Oncology Group performance status 0 or 1
(6) sufficient organ function
(7) written informed consent

Key exclusion criteria

(1) synchronous or metachronous malignancy
(2) pregnant or breastfeeding women

Target sample size

90


Research contact person

Name of lead principal investigator

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

Organization

Showa University Koto-Toyosu Hospital

Division name

Digestive Disease Center

Zip code


Address

5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan

TEL

03-6204-6000

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 Koto-Toyosu Hospital

Division name

Digestive Disease Center

Zip code


Address

5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan

TEL

03-6204-6000

Homepage URL


Email

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


Sponsor or person

Institute

Digestive Disease Center, Showa University Koto-Toyosu Hospital

Institute

Department

Personal name



Funding Source

Organization

Digestive Disease Center, Showa University Koto-Toyosu Hospital

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

2013 Year 01 Month 20 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

Completed

Date of protocol fixation

2013 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The possibility was showed that this technique could diagnose gastric and colonic cancer by using serum samples from the patients.


Management information

Registered date

2013 Year 01 Month 20 Day

Last modified on

2016 Year 04 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011505


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name