Clinical Significance of Occult Central Nervous System Localization

NCT05772000 | Unknown

• 1 other identifier: CampusALL2022
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• To assess the incidence of occult CNS localization in adult patients with ALL

  36 months

Interventions

cerebrospinal fluids exams DIAGNOSTIC_TEST

cerebrospinal fluids will be examined by conventional cytology and flow cytometry

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients affected by acute lymphoblastic leukemia

You may qualify if:

• Patients aged more than18 years with diagnosis of ALL at onset undergoing diagnostic-therapeutic PL.
• Signed written informed consent in accordance with ICH/EU/GCP guidelines and national and local laws.

You may not qualify if:

• Patients \<18 years of age
• Diagnosis other than ALL
• Inability to perform PL

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Tor Vergata University

Roma, RM, 00133, Italy

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Maria Ilaria Del Principe, Prof

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Ilaria Del Principe, Prof

CONTACT

+390620903219; del.principe@med.uniroma2.it

Maria Ilaria Del Principe

CONTACT

+390620903219; del.principe@med.uniroma2.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 16, 2023
• Study Start: September 8, 2020
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)