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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040494
Receipt No. R000046208
Scientific Title Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
Date of disclosure of the study information 2020/06/01
Last modified on 2020/05/22

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Basic information
Public title Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
Acronym Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
Scientific Title Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
Scientific Title:Acronym Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
Region
Japan

Condition
Condition anemia
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this cross-sectional study, we aim to assess the reliability of machine learning for digital image of palpable conjunctiva as predictive marker of anemia. The setting is the outpatient department and general internal medicine department of Dokkyo Medical University, a tertiary university hospital, Tochigi, Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary study outcome is a diagnostic accuracies (sensitivity, specificity, positive predictive value, negative predictive value and ROC curve by cross validation etc) of predictive hemoglobin from machine learning for digital image of palpebral conjunctiva. The reference standard is the patient's serum hemoglobin.
Key secondary outcomes The difference of the primary study outcome and the doctor's predictive value for the patient's serum hemoglobin

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 This study's participants will consist of patients who are performed the laboratory test to Outpatient department and general internal medicine department of Dokkyo Medical University, from May 2020 to April 2021.
Key exclusion criteria 1. Those who cannot get digital image of palpebral conjunctiva.
2. Those who do not consent to participate in this study.
Target sample size 800

Research contact person
Name of lead principal investigator
1st name Takanobu
Middle name
Last name Hirosawa
Organization Dokkyo Medical University
Division name Department of Diagnostic and Generalist Medicine
Zip code 321-0293
Address 880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
TEL 0282-86-1111
Email hirosawa@dokkyomed.ac.jp

Public contact
Name of contact person
1st name Takanobu
Middle name
Last name Hirosawa
Organization Dokkyo Medical University
Division name Department of Diagnostic and Generalist Medicine
Zip code 321-0293
Address 880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
TEL 0282-86-1111
Homepage URL
Email hirosawa@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University, Department of Diagnostic and Generalist Medicine
Institute
Department

Funding Source
Organization self funding
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 The Ethics Committee of Dokkyo Medical University
Address 880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
Tel 0282-86-1111
Email r-kenkyu@dokkyomed.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
2020 Year 06 Month 01 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
2020 Year 05 Month 02 Day
Date of IRB
2020 Year 05 Month 02 Day
Anticipated trial start date
2020 Year 05 Month 02 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The following information will be gathered from medical chart review
- age
- gender
- chief complain
- ethnic
- medical history until 2 weeks before (dyspnea, anorexia, body weight loss, fever, cold sweat, melena, blood stool, hematemesis)
- past medical history (congestive heart failure, ischemic heart disease, syncope, deep venous thrombosis, pulmonary embolism, pneumonia, gastrointestinal bleeding, cirrhosis and other liver diseases, diarrhea, transients ischemic attack, stroke, seizure, diabetic ketoacidosis, sepsis, HIV, tuberculosis and other infection, hematologic malignancy, thalassemia, kidney disfunction, collagen diseases, annual health check-up, hypertension, hyperlipidemia, diabetes, optic diseases, etc)
- blood infusion until 2 weeks before
- eye drops
- smoking history
- vital sign (blood pressure, heart rate, body temperature, respiratory rate, SpO2)
- laboratory data (Hb, Hct, RBC, MCV, MCH, MCHC, RDW, reticulocyte, rouleaux formation, WBC, platelet, CRP, ESR, lactate, Cre, BUN, AST, ALT, T-bil, Fe, TIBC, UIBC, ferritin, folate acid, vitamin B12, urinary test)
- final diagnosis

The following information will be gathered for this study
- digital image of palpebral conjunctiva
- predictive serum hemoglobin by doctor before laboratory data
- doctor's post graduate year

Management information
Registered date
2020 Year 05 Month 22 Day
Last modified on
2020 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046208

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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