UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036114 |
|---|---|
| Receipt number | R000041138 |
| Scientific Title | Exploratory study of hereditary porphyria diagnosis by porphyrin intermediate metabolite specific spectrum detection using liquid crystal tunable filter (LCTF) |
| Date of disclosure of the study information | 2019/03/06 |
| Last modified on | 2021/09/07 05:50:36 |
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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
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
sugitaka@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041138
