UMIN-CTR Clinical Trial

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
Email	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
Email	yokoyama@wakayama-med.ac.jp

Sponsor
Institute	National Hospital Organization Minami Wakayama Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050899