UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049671 |
|---|---|
| Receipt number | R000056526 |
| Scientific Title | Study on the Diagnosis of Non-Specific Abdominal Pain and Acute Hepatic Porphyria |
| Date of disclosure of the study information | 2022/12/03 |
| Last modified on | 2023/08/17 11:04:32 |
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Basic information
Public title
Study on the Diagnosis of Non-Specific Abdominal Pain and Acute Hepatic Porphyria
Acronym
Study on the Diagnosis of Non-Specific Abdominal Pain and Acute Hepatic Porphyria
Scientific Title
Study on the Diagnosis of Non-Specific Abdominal Pain and Acute Hepatic Porphyria
Scientific Title:Acronym
Study on the Diagnosis of Non-Specific Abdominal Pain and Acute Hepatic Porphyria
Region
| Japan |
Condition
Condition
Abdominal pain
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conducts this survey to suggest the definition of unexplained abdominal pain.
Basic objectives2
Others
Basic objectives -Others
Diagnostics
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Non-Specific Abdominal Pain
Key secondary outcomes
Acute Hepatic Porphyria
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 visited the Department of General Medicine of institutions from April 1, 2019 to March 31, 2022, and underwent either an abdominal CT scan, upper GI endoscopy, lower GI endoscopy, or abdominal ultrasound are included.
Key exclusion criteria
Patients who offer refusal to participate.
Target sample size
900
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
Profit organization
Nationality of Funding Organization
Japan
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
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）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 03 | 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
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Items of information to be obtained
Basic information regarding abdominal pain
-Age, sex, height, and body weight
-Route of transport to the medical institution
-Confirmed diagnosis. If a case does not have a confirmed diagnosis, we will collect the item unexplained abdominal pain.
-Suspected diseases
-Number of visits
-Whether or not the patient was referred to the Department of General Medicine
-Whether or not the patient has a history of visiting other departments
-Time of initial presentation of abdominal pain symptoms
-Number of incidences of abdominal pain
Test items
Whether or not the following tests have been performed so far:
-Electrocardiogram
-Blood tests
-Urine tests
-Abdominal imaging tests
-Pelvic ultrasound
Abdominal pain findings
Concurrent symptoms other than abdominal pain
Management information
Registered date
| 2022 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056526
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
