Optical Coherence Tomography (OCT) and OCT Angiography(OCTA) Deep Learning in Waldenström's Macroglobulinemia Patients

NCT ID: NCT06084650

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-10-01

Brief Summary

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This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in Waldenström's Macroglobulinemia patients, using optical coherence tomography angiography.

Detailed Description

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Waldenstrom macroglobulinemia (mak-roe-glob-u-lih-NEE-me-uh) is a rare type of cancer that begins in the white blood cells.

The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features. The study evaluates the changes in optical coherence tomography angiography features in Waldenstrom macroglobulinemia, elaborating these data with artificial intelligence.

Conditions

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Waldenstrom Macroglobulinemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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waldenstrom macroglobulinemia patients

No interventions assigned to this group

healthy patients matched age and sex without waldenstrom macroglobulinemia and ocular disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age older than 18 years

* diagnosis of Waldenstrom Macroglobulinemia
* absence of previous ocular surgery and congenital eye diseases.
* absence of errors of refraction
* absence of lens opacities
* absence of low-quality OCT and OCTA images

Exclusion Criteria

* • age younger than 18 years

* previous ocular surgery and congenital eye diseases
* errors of refraction
* lens opacities
* low-quality OCT and OCTA images
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Gilda Cennamo

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples "Federico II" Naples, Italy, 80100 Contact: Gilda Cennamo, MD 00390817143731 [email protected]

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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05809851

Identifier Type: -

Identifier Source: org_study_id

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