UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023350
Receipt number R000026315
Scientific Title Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors
Date of disclosure of the study information 2016/07/27
Last modified on 2016/10/18 05:29:38

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Basic information

Public title

Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors

Acronym

Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors

Scientific Title

Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors

Scientific Title:Acronym

Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors

Region

Japan


Condition

Condition

digestive malignant tumor

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

We examine the utility of endoscopic detection for digestive malignant tumors by using protoporphyrin IX fluorescence and endemism spectral detection, which accumulates selectively after 5-ALA administration.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The detection rate for malignant tumors by using protoporphyrin IX fluorescence and endemism spectral detection

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

2days

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

1) Age of patients at start of the trial is 20 years or older
2) Patients with digestive malignant tumors with the need of pathological diagnosis before treatment

Key exclusion criteria

1) Patients with porphyrinemia
2) Patients with hypersensitivity or a medical history with porphyrin related adverse events
3) People who have taken chemotheraphy for malignant tumors within one month before the start of the trial
4) Patients who have had other cancers
5) Patients who are taking anticoagulant or antithrombotic drugs
6) Women who are pregnant or are possibly pregnant
7) Patients with positive HBs antigen or HCV antibody

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuya Matsumoto

Organization

Department of Multidisciplinary Internal Medicine Faculty of Medicine,Tottori University

Division name

Division of Medicine and Clinical Science

Zip code


Address

36-1 Nishi-cho, Yonago 683-8504, Japan.

TEL

0859-38-6527

Email

matsumot@med.tottori-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Kurumi

Organization

Department of Multidisciplinary Internal Medicine Faculty of Medicine,Tottori University

Division name

Division of Medicine and Clinical Science

Zip code


Address

36-1 Nishi-cho, Yonago 683-8504, Japan.

TEL

0859-38-6527

Homepage URL


Email

kurumi_1022_1107@yahoo.co.jp


Sponsor or person

Institute

Tottori University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2016 Year 07 Month 27 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

Enrolling by invitation

Date of protocol fixation

2016 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 07 Month 27 Day

Last modified on

2016 Year 10 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026315


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name