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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

Tracking Information
First Submitted Date January 10, 2019
First Posted Date January 14, 2019
Last Update Posted Date January 16, 2019
Study Start Date January 1, 2007
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2019)
  • impact of occult CNS disease [ Time Frame: 10 years ]
    relapse rate
  • impact of occult CNS disease on outcome [ Time Frame: 10 years ]
    overall survival
Original Primary Outcome Measures
 (submitted: January 10, 2019)
incidence of occult CNS disease [ Time Frame: 10 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia
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
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients affected by ALL underwent to diagnostic lumbar puncture
Condition Acute Lymphoblastic Leukemia
Intervention Diagnostic Test: evaluation of cerebrospinal fluid of ALL
We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: evaluation of cerebrospinal fluid of ALL
Publications * 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, Sciumè M, Della Starza I, Venditti A, Foà 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. 2019 Dec 26. pii: haematol.2019.231704. doi: 10.3324/haematol.2019.231704. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 10, 2019)
241
Original Actual Enrollment Same as current
Actual Study Completion Date January 10, 2019
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ALL at onset
  • Age >18 years

Exclusion Criteria:

  • ALL relapsed or refractory
  • Age <18 years
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03803670
Other Study ID Numbers RS176/17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Maria Ilaria Del Principe, University of Rome Tor Vergata
Study Sponsor University of Rome Tor Vergata
Collaborators Not Provided
Investigators
Principal Investigator: Maria Ilaria Del Principe, MD University Tor Vergata of Rome
PRS Account University of Rome Tor Vergata
Verification Date January 2019