UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of protoporphyrin IX fluorescence and spectral detection in digestive malignant tumors
Title of the study (Brief title)	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	Kazuya Matsumoto
Organization	Department of Multidisciplinary Internal Medicine Faculty of Medicine,Tottori University
Division name	Division of Medicine and Clinical Science
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	Hiroki Kurumi
Organization	Department of Multidisciplinary Internal Medicine Faculty of Medicine,Tottori University
Division name	Division of Medicine and Clinical Science
Address	36-1 Nishi-cho, Yonago 683-8504, Japan.
TEL	0859-38-6527
Homepage URL
Email	kurumi_1022_1107@yahoo.co.jp

Sponsor
Institute	Tottori University
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026315