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

NCT02791217 | Unknown

• 1 other identifier: 2015097
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Molecular characteristics (by GEP, miRNA)

  1 year

Secondary Outcomes (2)

• Event free survival (EFS)

  0-5 years

• Overall survival (OS)

  0-5 years

Study Arms (5)

Diffused Large B cell Lymphoma

Follicular Lymphoma

Multiple Myeloma

Hodgkin Lymphoma

Healthy individuals

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diffused Large B cell Lymphoma Follicular Lymphoma Multiple Myeloma Hodgkin Lymphoma Healthy individuals

You may qualify if:

• 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.

You may not qualify if:

• Non-HIV/HCV/HBV Below age 18.

Sponsors & Collaborators

• Assuta Medical Center: lead
• Laniado Hospital: collaborator

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Central Study Contacts

Ofer Shpilberg, MD MPH

CONTACT

+972-3-7644364; ofers@assuta.co.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of hematology department

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 6, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2019
• Last Updated: June 6, 2016

Record last verified: 2016-06