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Identification of Hematological Malignancies and Therapy Predication Using microRNAs as a Diagnostic Tool

Identification of Hematological Malignancies and Therapy Predication Using microRNAs as a Diagnostic Tool

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02791217
Enrollment
100
Registered
2016-06-06
Start date
2016-06-30
Completion date
2019-06-30
Last updated
2016-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma, Hodgkin Lymphoma, Lymphoma, B-Cell, Multiple Myeloma

Brief summary

MiRNAs are small (\ 19-25 nucleotides) non-coding RNA molecules that bind to mRNA in a sequence-specific manner. MiRNAs regulate gene expression at the post-transcriptional level. MiRNAs regulate critical cell processes such as metabolism, apoptosis, development, cell cycle, hematopoietic differentiation and have been implicated in the development and progression of several types of cancers, including hematological malignancies. Over-expression, amplification and/or deletion of miRNAs and miRNA-mediated modification of epigenetic silencing can all lead to oncogenic pathways. Hematologic cancers, which are caused by the malignant transformation of bone marrow cells and the lymphatic system, are usually divided into three major clusters: leukemia, lymphoma, and multiple myeloma. To date, some of the hematological malignancies are very aggressive that early diagnosis is essential for improving prognosis and increasing survival rates. However, current diagnostic methods have various limitations, such as insufficient sensitivity, specificity, it is also time-consuming, costly, and requires a high level of expertise, which limits its application in clinical contexts. Thus, development of new biomarkers for the early detection and relapse of hematological malignancies is desirable. Some of the innate properties of miRNAs make them highly attractive as potential biomarkers. MiRNAs can be readily detected in small volume samples using specific and sensitive quantitative real-time PCR; they have been isolated from most body fluids, including serum, plasma, urine, saliva, tears and semen and are known to circulate in a highly stable, cell-free form. They are highly conserved between species, allowing the use of animal models of disease for pre-clinical studies. Furthermore, tumor cells have been shown to release miRNAs into the circulation and profiles of miRNAs are altered in the plasma and/or serum of patients with cancer. A growing number of publications confirm that miRNAs can be a useful biomarker for hematological malignancies diagnosis and progression.

Interventions

None listed

Sponsors

Laniado Hospital
CollaboratorOTHER
Assuta Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Newly diagnose patients with: Diffused large B cell lymphoma, Follicular lymphoma, Multiple myeloma and Hodgkin lymphoma. * Patients after chemotherapy (5-30 days). * Above age 18.

Exclusion criteria

* Non-HIV/HCV/HBV Below age 18.

Design outcomes

Primary

MeasureTime frame
Molecular characteristics (by GEP, miRNA)1 year

Secondary

MeasureTime frame
Event free survival (EFS)0-5 years
Overall survival (OS)0-5 years

Contacts

Primary ContactOfer Shpilberg, MD MPH
ofers@assuta.co.il+972-3-7644364

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026