NCT05490823

Brief Summary

The current standard for anemia screening, complete blood count, presents invasiveness, infrastructure requirements and high costs, leading to serious underestimation of anemia prevalence and insufficient care for anemia patients. Here, the investigators established and validated an artificial intelligence system to achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae. This system has been integrated into a smartphone app to be further validated through hospital-based and population-based clinical trials.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

4 years

First QC Date

August 4, 2022

Last Update Submit

August 4, 2022

Conditions

Anemia

Keywords

Smartphone appArtificial intelligencePublic health

Outcome Measures

Primary Outcomes (1)

  • The proportion of accurate, mistaken and missed detection of this smartphone app.

    27 months

Study Arms (1)

Eligible patients for app-based anemia screening

EXPERIMENTAL

Device: A smartphone app for anemia screening This app can achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae.

Device: A smartphone app for anemia screening

Interventions

A smartphone app for anemia screeningDEVICE

This app can achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae.

Eligible patients for app-based anemia screening

Eligibility Criteria

Age3 Years - 87 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients should be aware of the contents and signed for the informed consent.

You may not qualify if:

  • Patients who underwent ophthalmic or fingernail surgery in the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 8, 2022

Study Start

December 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Locations

CN(1)