Condition or disease | Intervention/treatment |
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Acute Lymphoblastic Leukemia | Diagnostic Test: evaluation of cerebrospinal fluid of ALL |
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 |
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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.
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Diagnostic Test: evaluation of cerebrospinal fluid of ALL
We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry
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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 |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Maria Ilaria Del Principe, MD | University Tor Vergata of Rome |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures |
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 |
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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
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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
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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. 2021 Jan 1;106(1):39-45. doi: 10.3324/haematol.2019.231704. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | Maria Ilaria Del Principe, University of Rome Tor Vergata | ||||
Study Sponsor | University of Rome Tor Vergata | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University of Rome Tor Vergata | ||||
Verification Date | January 2019 |