UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study of hereditary porphyria diagnosis by porphyrin intermediate metabolite specific spectrum detection using liquid crystal tunable filter (LCTF)
Acronym	Exploratory study of hereditary porphyria diagnosis by liquid crystal tunable filter (LCTF)
Scientific Title	Exploratory study of hereditary porphyria diagnosis by porphyrin intermediate metabolite specific spectrum detection using liquid crystal tunable filter (LCTF)
Scientific Title:Acronym	Exploratory study of hereditary porphyria diagnosis by liquid crystal tunable filter (LCTF)
Region	Japan

Condition
Condition	hereditary porphyria
Classification by specialty	Hepato-biliary-pancreatic medicine Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this exploratory study, we aimed to establish an more convenient diagnostic method for differential diagnosis of hereditary porphyria (especially, VP, HCP, EPP) by detecting the intrinsic fluorescence spectra of porphyrin intermediate metabolites (Uro III, Copro - III, Pp - IX) in urin/stool samples.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The differential diagnosis of hereditary porphyria (especially, VP, HCP, EPP) by detecting the intrinsic fluorescence spectra of porphyrin intermediate metabolites (Uro III, Copro - III, Pp - IX) in urin/stool samples using LCTF
Key secondary outcomes	1)Correlation between intrinsic fluorescence spectrum of porphyrin intermediate metabolite and results of HPLC analysis, genetic test(previously obtained). 2)Discrimination of difference in detectability by various clinical samples (urine/stool) 3)Correlation between intrinsic fluorescence spectrum of porphyrin intermediate metabolite and clinical data (gender, age, blood biochemistry data)

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who satisfy all the following criteria are targeted. 1) Clinically suspected of porphyria 2) Persons who have already been confirmed for genetic porphyria already by gene / HPLC etc.
Key exclusion criteria	Patients who conflict with one of the following will not be included in this clinical study. 1) Patients with lead poisoning, liver diseases such as liver cirrhosis / liver cancer, blood diseases such as iron deficiency anemia and sideroblastic anemia, hypermetabolism, endocrine diseases 2) Patients suspected of elemental poisoning such as arsenic and mercury. 3) Patients suspected of intoxication of polyaromatic halide compounds such as dioxin and PCB. 4) Patients taking phenobarbital, cedlumide, griseofulvin, carbamazepine 5) Others who the research researcher deems inappropriate as a patient.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takaaki Middle name Last name Sugihara
Organization	Tottori University Faculty of Medicine
Division name	Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, School of Medicine,
Zip code	6838504
Address	36-1 Nishi-cho, Yonago, Tottori
TEL	0859386527
Email	sugitaka@tottori-u.ac.jp

Public contact
Name of contact person	1st name Takaaki Middle name Last name Suighara
Organization	Tottori University Faculty of Medicine
Division name	Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, School
Zip code	6838504
Address	36-1 Nishi-cho, Yonago, Tottori
TEL	0859386527
Homepage URL
Email	sugitaka@tottori-u.ac.jp

Sponsor
Institute	Tottori University Faculty of Medicine
Institute
Department

Funding Source
Organization	Tottori University Faculty of Medicine
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	Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital
Address	36-1, Nishi-cho, Yonago city, Tottori prefecture, Japan, 683-8504,
Tel	0859-38-7108
Email	me-rinshoukenkyu@ml.adm.tottori-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	2019 Year 03 Month 06 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	2018 Year 12 Month 19 Day
Date of IRB	2018 Year 12 Month 07 Day
Anticipated trial start date	2019 Year 12 Month 19 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Now enrolling

Management information
Registered date	2019 Year 03 Month 06 Day
Last modified on	2021 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041138