UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040494 |
|---|---|
| Receipt number | 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 | 2022/11/23 10:44:39 |
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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
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
hirosawa@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University, Department of Diagnostic and Generalist Medicine
Institute
Department
Personal name
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
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
Terminated
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
| 2022 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046208
