UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000031130
Receipt number R000035559
Scientific Title Observational study on biomarker search of gastrointestinal tumors by flow cytometry
Date of disclosure of the study information 2018/02/20
Last modified on 2018/02/04 00:27:45

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Basic information

Public title

Observational study on biomarker search of gastrointestinal tumors by flow cytometry

Acronym

Observational study on biomarker search of gastrointestinal tumors by flow cytometry

Scientific Title

Observational study on biomarker search of gastrointestinal tumors by flow cytometry

Scientific Title:Acronym

Observational study on biomarker search of gastrointestinal tumors by flow cytometry

Region

Japan


Condition

Condition

Esophageal cancer, Gastric cancer, Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery Radiology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Quantitatively evaluate the cell cycle status of the tumor tissue cells using a rapid flow cytometric machine called Celltac PEAK and compare it with the clinicopathological factor, therapeutic effect, prognosis and establish a new biomarker As the aim of this research.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival

Key secondary outcomes

relapse free / progression-free survival period, pathology result, tumor marker etc., treatment effect (RECIST), numerical value measurable by image (tumor size, contrast effect, FDG-PET sugar metabolic rate, ADC value etc. ), Tumor genetic mutation (colon cancer)


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients aged 20 years or older who received a sufficient explanation about this research and received understanding and document consent by free will.

Key exclusion criteria

In the case of insufficient tissue volume for this examination during endoscopic examination or surgery.
When consent on this research can not be obtained.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisahiro Matsubara

Organization

Graduate school of medicine, Chiba University

Division name

Department of frontier surgery

Zip code


Address

1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba

TEL

043-226-2109

Email

matsuhm@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Amagai

Organization

Graduate school of medicine, Chiba University

Division name

Department of frontier surgery

Zip code


Address

1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba

TEL

043-226-2109

Homepage URL


Email

afua2633@chiba-u.jp


Sponsor or person

Institute

Graduate school of medicine, Chiba University

Institute

Department

Personal name



Funding Source

Organization

NIHON KOHDEN CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

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

2018 Year 02 Month 20 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 01 Month 06 Day

Date of IRB


Anticipated trial start date

2017 Year 04 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

Analyze the DNA histogram of tissues using Celltac PEAK and quantitatively evaluate the cell cycle state of tumor cells in the tissue.


Management information

Registered date

2018 Year 02 Month 04 Day

Last modified on

2018 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035559


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name