NCT06574308

Brief Summary

Digital morphology is currently expanding and developing new applications based on artificial intelligence software. We recently published a study comparing screen validation and microscopic reading of bone marrow aspirates. The aim of the current research will be the comparison between optical microscope reading and automatic pre-classification (AI based)

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 26, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 26, 2024

Last Update Submit

August 26, 2024

Conditions

Blood Cancer

Outcome Measures

Primary Outcomes (1)

  • Optical microscope reading and automatic pre-classification

    Comparison between optical microscope reading and automatic pre-classification (AI based)

    12 months

Interventions

Blood cells classificationDIAGNOSTIC_TEST

Comparison of the classification of peripheral blood and bone marrow cells with optical microscope reading with pre-classification using Scopio technology (AI based)

Eligibility Criteria

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

Pazienti affetti da emopatie

You may qualify if:

  • Patients suffering from hemopathies with bone marrow aspirate assessable under the optical microscope

You may not qualify if:

  • Patients not affected by blood disorders
  • Patients suffering from hemopathies with bone marrow aspirate that cannot be assessed under the optical microscope

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Patrizia Chiusolo

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizia Chiusolo, MD

CONTACT

+390630154206patrizia.chiusolo@unicatt.it

Elena Rossi, MD

CONTACT

+390630154206elena.rossi@unicatt.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2024

First Posted

August 27, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations

IT(1)