UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054495 |
|---|---|
| Receipt number | R000062249 |
| Scientific Title | Assessment of the utility of Hoesch test assay as initial screening test for acute hepatic porphyria in Japan |
| Date of disclosure of the study information | 2024/05/28 |
| Last modified on | 2025/02/04 14:58:06 |
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Basic information
Public title
Assessment of the utility of Hoesch test assay as initial screening test for acute hepatic porphyria in Japan
Acronym
Assessment of the utility of Hoesch test assay as initial screening test for acute hepatic porphyria in Japan
Scientific Title
Assessment of the utility of Hoesch test assay as initial screening test for acute hepatic porphyria in Japan
Scientific Title:Acronym
Assessment of the utility of Hoesch test assay as initial screening test for acute hepatic porphyria in Japan
Region
| Japan |
Condition
Condition
acute hepatic porphyria
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Urine PBG, quantitative ALA testing, and urinalysis with Hoesch reagent will be performed in patients with abdominal pain of unknown diagnosis to confirm the usefulness of urinalysis in AHP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The PBG screening test with the Hoesch reagent will be compared to the PBG quantitative test, and the sensitivity and specificity will be calculated using the PBG quantitative test results as the gold standard. In addition, the positive concordance rate, negative concordance rate, false positive rate, and false negative rate of the Hoesch reagent will be evaluated to assess factors affecting test results.
Key secondary outcomes
Calculate the incidence of AHP and evaluate factors that influence the diagnosis of AHP.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients meeting the definition of NSAP who are seen at each practitioner's office, who are under 65 years of age at the time of their first visit, and who are suspected of having AHP.
Key exclusion criteria
(1) Persons 65 years of age or older
(2) Persons who do not plan to perform the quantitative urine PBG test (only if the quantitative urine PBG test is not available, persons who do not plan to perform the quantitative urine ALA test)
(3) Persons who refuse to participate in this study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Tazuma |
Organization
MEDICAL CORPORATION JR HIROSHIMA HOSPITAL / JA Onomichi General Hospital
Division name
Hospital DirectorHonorary / Director,Advisor
Zip code
732-0057 / 722-8508
Address
3-1-36 Futabanosato, Higashi-ku, Hiroshima, Hiroshima / 1-10-23 Hirahara, Onomichi, Hiroshima
TEL
082-262-1171.0848-22-8111
stazuma@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
849-0937
Address
5-1-1 Nabeshima, Saga-shi, Saga
TEL
0952-31-6511
Homepage URL
tagomas@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
Alnylam Japan K.K.
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
Clinical Research Center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga-shi, Saga
Tel
0952-34-3400
clinstudycenter@mail.admin.saga-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
JR広島病院（広島県）
JA尾道総合病院（広島県）
佐賀大学医学部附属病院（佐賀県）
東邦大学医療センター大森病院（東京都）
福岡大学病院（福岡県）
順天堂大学医学部附属順天堂医院（東京都）
獨協医科大学病院（栃木県）
大分大学医学部附属病院(大分県)
岩国市立美和病院(山口県)
岡山大学病院(岡山県)
長崎大学病院(長崎県)
垂水市立医療センター垂水中央病院(鹿児島県)
三重大学医学部附属病院(三重県)
東京都済生会中央病院(東京都)
原土井病院(福岡県)
宮崎県立宮崎病院(宮崎県)
兵庫医科大学病院(兵庫県)
湘南鎌倉総合病院(神奈川県)
群馬大学医学部附属病院(群馬県)
広島市立北部医療センター 安佐市民病院(広島県)
日本医科大学付属病院(東京都)
岩手県立中央病院(岩手県)
九州大学病院(福岡県)
島根県立中央病院(島根県)
防衛医科大学校病院(埼玉県)
岩手県立胆沢病院(岩手県)
岐阜大学医学部附属病院(岐阜県)
自治医科大学附属さいたま医療センター(埼玉県)
鳥取市立病院(鳥取県)
東北大学病院(宮城県)
広島赤十字・原爆病院(広島県)
TMGあさか医療センター(埼玉県)
日本医大武蔵小杉病院(神奈川県)
南薩ケアほすぴたる(鹿児島県)
西予市立野村病院(愛媛県)
岩国市立錦中央病院(山口県)
愛媛大学医学部附属病院(愛媛県)
岩手医科大学附属内丸メディカルセンター(岩手県)
広島大学病院(広島県)
大阪府済生会千里病院(大阪府)
市立美唄病院(北海道)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Basic patient information
Age, sex, height, weight
Items corresponding to the definition of NSAP
Abdominal imaging
Blood test
Date of abdominal pain
Date of initial medical examination
Date of diagnosis of NSAP
Date when consent was obtained
Symptoms associated with AHP
Location of abdominal pain during the course of the disease
The degree of abdominal pain during the course of the disease
Peripheral neurological symptoms
Central nervous system symptoms
Central nervous system symptoms
Laboratory test results
Urinary Cr level
Urinary PBG level
Urinary ALA level
Gene test results
Urinalysis results using Hoesch's reagent
Adverse events
Management information
Registered date
| 2024 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062249
