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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02791217
• Other study ID #: 2015097
• Status: Not yet recruiting
• Phase: N/A
• First received: May 30, 2016
• Last updated: June 3, 2016
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: June 2016
• Source: Assuta Medical Center
• Contact: Ofer Shpilberg, MD MPH
• Phone: +972-3-7644364
• Email: ofers[@]assuta.co.il
• Is FDA regulated: No
• Health authority: Israel: Minstry of health (MOH)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2019
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assuta Medical Center	Laniado Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular characteristics (by GEP, miRNA)		1 year	No
Secondary	Event free survival (EFS)		0-5 years	No
Secondary	Overall survival (OS)		0-5 years	No