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UMIN-CTR Clinical Trial |
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Name: | 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 |
Basic information | ||
Public title | Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
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Acronym | Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
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Scientific Title | Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
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Scientific Title:Acronym | Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
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Region |
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Condition | |||
Condition | anemia | ||
Classification by specialty |
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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 | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
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Eligibility | ||||
Age-lower limit |
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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. |
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Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Results | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046208 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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