To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Significance of Occult Central Nervous System Localization
NCT ID:
NCT05772000
Condition:
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
cerebrospinal fluids exams
Description:
cerebrospinal fluids will be examined by conventional cytology and flow cytometry
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"
Detailed description:
The investigators propose a multicenter prospective study to evaluate the incidence of
occult CNS localization and the impact of such localization on clinical outcome.Adult ALL
patients routinely undergo diagnostic lumbar puncture (PL); cerebrospinal fluids (CSF
)samples will be studied by investigation of conventional cytology (CC) and FCM at the
time of the first and subsequent diagnostic PLs.
Criteria for eligibility:
Study pop:
Adult patients affected by acute lymphoblastic leukemia
Sampling method:
Non-Probability Sample
Criteria:
Inclusion criteria.
- 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.
Exclusion criteria.
- Patients <18 years of age
- Diagnosis other than ALL
- Inability to perform PL
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tor Vergata University
Address:
City:
Roma
Zip:
00133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maria Ilaria Del Principe
Phone:
3394080659
Email:
del.principe@med.uniroma2.it
Start date:
September 8, 2020
Completion date:
September 8, 2024
Lead sponsor:
Agency:
University of Rome Tor Vergata
Agency class:
Other
Source:
University of Rome Tor Vergata
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05772000
