UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031289
Receipt number R000035720
Scientific Title The analysis of new chemical parameter in blood samples of active Ulcerative Colitis patients by Raman scattering spectroscopy.
Date of disclosure of the study information 2018/02/13
Last modified on 2023/02/17 22:20:10

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Basic information

Public title

The analysis of new chemical parameter in blood samples of active Ulcerative Colitis patients by Raman scattering spectroscopy.

Acronym

The analysis of new parameters in serum samples of UC patients.

Scientific Title

The analysis of new chemical parameter in blood samples of active Ulcerative Colitis patients by Raman scattering spectroscopy.

Scientific Title:Acronym

The analysis of new parameters in serum samples of UC patients.

Region

Japan


Condition

Condition

Ulcerative Colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify potential serologic biomarkers for assessing UC activity and monitoring efficacy of treatment

Basic objectives2

Others

Basic objectives -Others

biochemical examination

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1:Try to identify molecules that could correlate with endoscopic findings(UC-EIS) before treatment and at 10 weeks on therapy.
2:To test whether a novel biomarker could be used to predict mucosal healing at 1 year after treatment initiation.

Key secondary outcomes

1:To evaluate the correlation between the new biomarker(s) and UCDAI score at 1,4,10 weeks and 1year after treatment.
2:To evaluate the correlation between the new biomarker(s) and Matts grade at 10 weeks after treatment.


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

Patients who have received complete information about the study and are willing to provide written informed consent.

Key exclusion criteria

1:Inability or unwillingness of patients to give written informed consent
2:Judged unsuitable for this study by the physician

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Akiko
Middle name
Last name Toshimori

Organization

Showa University Koto Toyosu Hospital

Division name

Digestive Disease Center

Zip code

1358577

Address

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

TEL

03-6204-6000

Email

akikotoshimori@med.showa-u.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Toshimori

Organization

Showa University Koto Toyosu Hospital

Division name

Digestive Disease Center

Zip code

1358577

Address

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

TEL

03-6204-6000

Homepage URL


Email

akikotoshimori@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University Koto Toyosu Hospital

Institute

Department

Personal name



Funding Source

Organization

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

Showa University Koto Toyosu Hospital

Address

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

Tel

0362046000

Email

th_irb@ofc.showa-u.ac.jp


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 13 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

Completed

Date of protocol fixation

2017 Year 12 Month 07 Day

Date of IRB

2017 Year 12 Month 27 Day

Anticipated trial start date

2018 Year 01 Month 31 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

discribed in the "Assesment" column


Management information

Registered date

2018 Year 02 Month 13 Day

Last modified on

2023 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035720


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name