Clinical Significance of Occult Central Nervous System Localization

NCT05772000 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2023-03-22

No results posted yet for this study

Summary

In acute lymphoblastic leukemia (ALL), the occult central nervous system (CNS) involvement appears to be associated with poor prognosis. Flow cytometry (FCM) allows detection of occult CNS localization. The current international guidelines do not recommend the use of FCM in the assessment of CNS at onset in adult ALL patients. Large-scale prospective studies will help to clarify whether or not patients with occult CNS localization should undergo CNS-directed therapy. Understanding this seems particularly important nowadays considering that with the introduction of new drugs (monoclonal antibodies, next-generation tyrosine kinase inhibitors, CAR-T) the therapeutic approach of patients with ALS is increasingly "chemo-free"

Conditions

Interventions

DIAGNOSTIC_TEST

cerebrospinal fluids exams

cerebrospinal fluids will be examined by conventional cytology and flow cytometry

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • Maria Ilaria Del Principe, Prof · University of Rome Tor Vergata

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2023-09-08
Completion
2024-09-08

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05772000 on ClinicalTrials.gov