UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044557 |
|---|---|
| Receipt number | R000050899 |
| Scientific Title | The severity diagnosis of acute abdomen by serum CEACAM 1 level |
| Date of disclosure of the study information | 2021/06/16 |
| Last modified on | 2021/06/16 11:25:17 |
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Basic information
Public title
The severity diagnosis of acute abdomen by serum CEACAM 1 level
Acronym
The severity diagnosis of acute abdomen by serum CEACAM 1 level
Scientific Title
The severity diagnosis of acute abdomen by serum CEACAM 1 level
Scientific Title:Acronym
The severity diagnosis of acute abdomen by serum CEACAM 1 level
Region
| Japan |
Condition
Condition
acute abdomen
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Significance of serum CEACAM1 in the severity of acute abdomen
Basic objectives2
Others
Basic objectives -Others
Clinical usefulness of serum CEACAM1 in the severity of acute abdomen
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association of serum CEACAM1 with the severity of acute abdomen
Key secondary outcomes
The evaluation of Clinical course and prognosis of patients with acute abdomen by serum CEACAM1 level
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who visited the hospital due to acute abdomen and underwent surgery.
2. The age at the time of obtaining consent is 20 years or older.
3. Understand the research content and obtain the consent of the patient in writing.
Key exclusion criteria
1. Patients who do not agree.
2. Patients that the doctor or responsible doctor deems inappropriate.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shozo |
| Middle name | |
| Last name | Yokoyama |
Organization
National Hospital Organization Minami Wakayama Medical Center
Division name
Surgery
Zip code
646-8558
Address
27-1 Takinaicho, Tanabe, Wakayama 646-8558
TEL
+81-739-26-7050
yokoyama@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shozo |
| Middle name | |
| Last name | Yokoyama |
Organization
National Hospital Organization Minami Wakayama Medical Center
Division name
Surgery
Zip code
646-8558
Address
27-1 Takinaicho, Tanabe, Wakayama 646-8558
TEL
+81-739-26-7050
Homepage URL
yokoyama@wakayama-med.ac.jp
Sponsor or person
Institute
National Hospital Organization Minami Wakayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Minami Wakayama Medical Center
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
National Hospital Organization Minami Wakayama Medical Center
Address
27-1 Takinaicho, Tanabe, Wakayama 646-8558
Tel
+81-739-26-7050
yokoyama@wakayama-med.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
| 2021 | Year | 06 | Month | 16 | 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
| 2021 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The test has started and is ongoing.
Management information
Registered date
| 2021 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050899
| Research Plan | |
|---|---|
| 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 |
