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

NCT ID: NCT02791217

Last Updated: 2016-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diffused Large B cell Lymphoma

No interventions assigned to this group

Follicular Lymphoma

No interventions assigned to this group

Multiple Myeloma

No interventions assigned to this group

Hodgkin Lymphoma

No interventions assigned to this group

Healthy individuals

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laniado Hospital

OTHER

Sponsor Role: collaborator

Assuta Medical Center

OTHER

Sponsor Role: lead

Responsible Party

shpilberg ofer

Head of hematology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ofer Shpilberg, MD MPH

Role: CONTACT

ofers@assuta.co.il

+972-3-7644364

Other Identifiers

2015097

Identifier Type: -

Identifier Source: org_study_id