UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017045
Receipt number R000019772
Scientific Title Development of histopathological methodology without staining using a spectroscopy
Date of disclosure of the study information 2015/04/04
Last modified on 2017/10/04 09:15:03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Development of histopathological methodology without staining using a spectroscopy

Acronym

NOn-staining histopathological methodology using a spectroscopy

Scientific Title

Development of histopathological methodology without staining using a spectroscopy

Scientific Title:Acronym

NOn-staining histopathological methodology using a spectroscopy

Region

Japan


Condition

Condition

Esophageal, gastric, colorectal, hepatic, pancreatic, bile duct, and gallbladder cancer

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Adult

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

1. Development of histopathological diagnostic method without staining for gastrointestinal, hepatic, pancreatic, and gallbladder cancer.
2. Development of method detecting circulating tumor cells without labeling.
3. Development of method detecting substances related diseases without labeling.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Accuracy of diagnosis of cancer cells by spectroscopy.

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 cancer. And benign disease patients without cancer.
(2) age 20-80 years.
(3) Eastern Cooperative Oncology Group. performance status 0 or 1.
(4) sufficient organ function.
(5) written informed consent.

Key exclusion criteria

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

Target sample size

250


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

2015 Year 04 Month 04 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

Suspended

Date of protocol fixation

2015 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2015 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

Comparison of diagnosis between spectroscopy and normal histopathological examination.


Management information

Registered date

2015 Year 04 Month 04 Day

Last modified on

2017 Year 10 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019772


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name