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Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT03803670
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Ilaria Del Principe, University of Rome Tor Vergata

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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Diagnostic Test: evaluation of cerebrospinal fluid of ALL

Detailed Description:
Demographic and of laboratory data of 241 adult patients with ALL were retrospectively recorded. All patients underwent diagnostic lumbar puncture and each cerebrospinal fluid sample was examined by CC and FCM. The investigators identified patients with the only FCM positivity and the investigators correlated this condition with clinical and of laboratory data and with clinical outcome.

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Study Type : Observational
Actual Enrollment : 241 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia: A Multicenter, Retrospective Study From The Campus All/Gimema Network
Study Start Date : January 1, 2007
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 10, 2019


Group/Cohort Intervention/treatment
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.
Diagnostic Test: evaluation of cerebrospinal fluid of ALL
We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry




Primary Outcome Measures :
  1. impact of occult CNS disease [ Time Frame: 10 years ]
    relapse rate

  2. impact of occult CNS disease on outcome [ Time Frame: 10 years ]
    overall survival



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients affected by ALL underwent to diagnostic lumbar puncture
Criteria

Inclusion Criteria:

  • ALL at onset
  • Age >18 years

Exclusion Criteria:

  • ALL relapsed or refractory
  • Age <18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803670


Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
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Principal Investigator: Maria Ilaria Del Principe, MD University Tor Vergata of Rome
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Ilaria Del Principe, PI, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT03803670    
Other Study ID Numbers: RS176/17
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Ilaria Del Principe, University of Rome Tor Vergata:
acute lymphoblastic leukemia
flow cytometry
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Nervous System Diseases
Central Nervous System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases