"Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia - TRINEG-ALL
"Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia: Molecular Characterization, Identification and New Stratification
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
60 participants
Oct 23, 2019
OBSERVATIONAL
Conditions
Summary
It is a multicenter, non-interventional, non pharmacological, translational, prospective study. Any decision about drug administration is made by the physician based on his clinical judgment in the context of clinical practice, independently from the decision to include the patient in the study.
Eligibility
Inclusion Criteria6
- Participant is willing and able to give informed consent for participation in the study;
- Patients with new diagnosis and/or relapse/s of primary or secondary B-ALL;
- Negative for BCR-ABL1 t(9;22); TCF3-PBX1 t(1;19); MLL-AF4 t(4;11) rearrangements;
- Participant is willing and able to give informed consent for participation in the study;
- Male or Female, aged \>18 years;
- Availability of clinical data.
Exclusion Criteria3
- Age \< 18 years;
- B-ALL positive for BCR-ABL1 t(9;22); TCF3-PBX1 t(1;19); MLL-AF4 t(4;11) rearrangements.
- Low blast percentage (\<70%) samples could be excluded for molecular evaluations, not for cytofluorimetric analyses;
Interventions
Samples will be studied with conventional techniques to classify and define properly the disease: morphology, immunophenotype, immunohistochemistry (IHC), conventional Cytogenetic Fluorescence in Situ Hybridization (FISH) will be used when appropriate. ● Isolation of Mononuclear cells The following research methodologies will be applied: * Next Generation Sequencing * Flow cytometry analysis of 3C-up B-ALL top three markers * Gene expression profile analysis * Copy number Alterations analysis * In vitro studies
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06919393