NCT06084650

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

October 10, 2023

Last Update Submit

May 21, 2024

Conditions

Waldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • The measurements of retinal and choriocapillary vessel density in Waldenstrom Macroglobulinemia patients.

    The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device

    up to three months

Study Arms (2)

waldenstrom macroglobulinemia patients

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participans were older than 18 years with diagnosis of Waldenstrom Macroglobulinemia. They did not present other ophthalmological disease

You may qualify if:

  • 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

You may not qualify if:

  • age younger than 18 years
  • previous ocular surgery and congenital eye diseases
  • errors of refraction
  • lens opacities
  • low-quality OCT and OCTA images

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples "Federico II" Naples, Italy, 80100 Contact: Gilda Cennamo, MD 00390817143731 xgilda@hotmail.com

Napoli, Italy

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

January 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 1, 2023

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

IT(1)