Recruiting NCT07445984

Chemogenomic Profiling in Hematological Malignancies (HEM-Profiling 2021)

No phase Interventional Chronic Leukemia Acute Leukemia Myeloproliferative Disorders Lymphoproliferative Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Genetic, molecular and/or omics analyses.
Who it may be relevant to: Registry conditions: Chronic Leukemia, Acute Leukemia, Myeloproliferative Disorders, Lymphoproliferative Disorders. Basic parameters: from 1 year · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The study will be conducted retrospectively and prospectively, using bone marrow (BM) or peripheral blood (PB) samples or biopsies of lymph nodes or tissues with metastatic involvement taken from previously stored samples here at the University Hospital of Parma or taken from patients that need to underwent diagnostic evaluation for a suspect or a defined diagnosis of hematological malignancies collected at the University Hospital of Parma.

Detailed description

The hematological malignancies are referred to all the different hematological entities according to WHO 2016 Classification such as acute (AML, ALL) or chronic leukemia (CLL, CML, HCL), myeloproliferative or lymphoproliferative disorders (MF, PV, TE, CMML, NHL, HL) and myelodysplastic or myelodysplastic/myeloproliferative disorders.

Interventions

Other Genetic, molecular and/or omics analyses
The focus of our scientific approach is based on genetic, molecular and/or omics analyses performed with new technologies (Nanostring, NGS, single cell technologies, radiomics)

Primary outcome measures

To evaluate the anti-cancer activity of bio-active compounds and derivatives present in FDA/EMA approved or investigator provided libraries, investigational molecules [Time frame: At baseline]
To characterize molecular biomarkers for the identification of novel target therapies [Time frame: At baseline]
Correlate anti-cancer response with diagnostic (WHO classification) and molecular or novel omics features including cytogenetics, genomics, next generation or single cell technologies, radiomics. [Time frame: At baseline]

Eligibility criteria

Inclusion criteria

Patient aged >1 year old, referred for evaluation to the University Hospital of Parma;
Retrospective study: previously patients with hematological malignancies;
Prospective study: 1) patients with clinical suspect of hematological malignancies which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate/biopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc. 2) patients with clinical suspect of relapsed/refractory onco-hematological disorder, which requires a diagnostic assessment using bone marrow aspirate/biopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from rachicentesis, tissue aspirate etc. 3) patients that progress in blastic transformation from a chronic condition or suspect of relapsed/refractory hematological disease, which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate/biopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc;
Written informed consent. Retrospective study: informed consent will be signed during the first follow-up visit.

Exclusion criteria

Age <1 year old
Patients who are unable to provide informed consent prior to any procedure for any reason.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Basic science

Study locations

Italy · 1 center

University of Parma — Parma

Identifiers

NCT: NCT07445984 · 114/2021/TESS/UNIPR

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗