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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name