UMIN-CTR Clinical Trial

Basic information
Public title	Diagnosis of pancreatobiliary cancer by measuring the urinary and serum levels of porphyrins after oral administration of 5-aminolevulinic acid.
Acronym	Diagnosis of pancreatobiliary cancer by measuring the urinary and serum levels of porphyrins.
Scientific Title	Diagnosis of pancreatobiliary cancer by measuring the urinary and serum levels of porphyrins after oral administration of 5-aminolevulinic acid.
Scientific Title:Acronym	Diagnosis of pancreatobiliary cancer by measuring the urinary and serum levels of porphyrins.
Region	Japan

Condition
Condition	Patients who have suspected pancreatobiliary disease.
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine whether the urinary and serum levels of porphyrins (porphyrinogenI, coproporphyrinogenI, coproporphyrinogenIII, protoporhyrinIX) after oral administration of 5-aminolevulinic acid are potential markers for diagnosis of pancreatobiliary cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The urinary and serum levels of porphyrins after oral administration of 5-aminolevulinic acid in pancreaticobiliary lesions.
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	Food
Interventions/Control_1	Oral administration of 5-aminolevulinic acid
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	1. Patients 20 years of age and older who have an abnormality of biliary tree or pancreas. 2. Patients who provide a written informed consent.
Key exclusion criteria	1. Patients with porphyria. 2. Patients with hypersensitivity to 5-aminolevulinic acid or porphyrins. 3. In cases of known or suspected pregnancy or woman who are breast-feeding. 4. Patients who doctors regard as inappropriate ones for the enrollment due to some reasons.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tsukasa Ikeura
Organization	Kansai Medical University
Division name	The Third Department of Internal Medicine
Zip code
Address	2-5-1, Shinmachi, Hirakata, Osaka, Japan
TEL	072-804-0101
Email	ikeurat@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tsukasa Ikeura
Organization	Kansai Medical University
Division name	The Third Department of Internal Medicine
Zip code
Address	2-5-1, Shinmachi, Hirakata, Osaka, Japan
TEL	072-804-0101
Homepage URL
Email	ikeurat@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	None
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 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	67
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	2015 Year 03 Month 01 Day
Date of IRB	2015 Year 09 Month 14 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 27 Day
Last modified on	2021 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019352