Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia
1 other identifier
observational
241
0 countries
N/A
Brief Summary
Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. The investigators have previously reported that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in samples with low cell counts. In the framework of the national Campus ALL program aimed at improving the management of adult ALL patients in the context of the GIMEMA protocols, in the present study the investigators retrospectively evaluated the incidence of occult CNS positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13 centers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2007
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2019
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedJanuary 16, 2019
January 1, 2019
12 years
January 10, 2019
January 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
impact of occult CNS disease
relapse rate
10 years
impact of occult CNS disease on outcome
overall survival
10 years
Study Arms (1)
acute lymphoblastic leukemia patients
We observed within adult patients with ALL three groups of patients: patients without central nervous system (CNS) involvement, patients with manifest CNS involvement and patients with occult CNS involvement.
Interventions
We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry
Eligibility Criteria
Adult patients affected by ALL underwent to diagnostic lumbar puncture
You may qualify if:
- ALL at onset
- Age \>18 years
You may not qualify if:
- ALL relapsed or refractory
- Age \<18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Del Principe MI, Buzzatti E, Piciocchi A, Forghieri F, Bonifacio M, Lessi F, Imbergamo S, Orciuolo E, Rossi G, Fracchiolla N, Trappolini S, Neri B, Sarlo C, Zappasodi P, Dargenio M, Cefalo M, Irno-Consalvo MA, Conti C, Paterno G, De Angelis G, Sciume M, Della Starza I, Venditti A, Foa R, Guarini AR. Clinical significance of occult central nervous system disease in adult acute lymphoblastic leukemia. A multicenter report from the Campus ALL Network. Haematologica. 2021 Jan 1;106(1):39-45. doi: 10.3324/haematol.2019.231704.
PMID: 31879328DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Ilaria Del Principe, MD
University Tor Vergata of Rome
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
January 10, 2019
First Posted
January 14, 2019
Study Start
January 1, 2007
Primary Completion
January 1, 2019
Study Completion
January 10, 2019
Last Updated
January 16, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share