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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03185325
Other study ID # AssiutUniversity
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 10, 2018
Est. completion date December 24, 2019

Study information

Verified date January 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Lymphomas are hematological malignancies, which are divided into non-Hodgkin lymphoma and Hodgkin lymphoma. Non hodgkin lymphoma is a lymphoma-derived malignancy that makes up about 90% of all malignant lymphoma. According to its origin, non hodgkin lymphoma is classified into B-cell non hodgkin lymphoma and T-cell non hodgkin lymphoma. The most common types are follicular lymphoma, and diffuse large B-cell lymphoma. Lymphomas are types of cancer that develops from lymphocytes, a type of white blood cell. Diagnosis is by examination of a bone marrow or lymph node biopsy. Non hodgkin lymphoma mortality has increased in recent years and has become the seventh most frequently occurring cancer.


Description:

Biomarkers are defined as objective indicators of biological processes, pathogenic processes, or pharmacological response to a therapeutic intervention. Diagnostic biomarkers which are type of biomarkers, identify the presence of disease, differentiate normal from malignant, distinguish different diagnoses or progression stages. Micro ribosomal nucleic acids have been demonstrated to possess biomarker potentiality in multiple diseases, both individually and when combined in signature profiles. Micro ribosomal nucleic acids are short single-stranded noncoding ribosomal nucleic acids of 20-22 nucleotides that function to regulate gene expression at the posttranscriptional level. They play fundamental roles in the regulation of cellular proliferation, differentiation, and apoptosis. Dysregulation of micro ribosomal nucleic acid is a unique feature of cancers including lymphomas . Information about the functional role of micro ribosomal nucleic acid dysregulation in lymphomas is increasing day by day. The present study focuses on the micro ribosomal nucleic acid 155 since this molecule represents a typical multifunctional micro ribosomal nucleic acid. To date, increased evidence points out that micro ribosomal nucleic acid 155 is involved in numerous biological processes including haematopoiesis, inflammation and immunity. Deregulation of micro ribosomal nucleic acid 155 has been found to be associated with different kinds of cancer, cardiovascular diseases and viral infections. Since investigation on the functional activity of micro ribosomal nucleic acid 155 started a few years ago, it is reasonable to predict that many other functions will be uncovered in the near future. Micro ribosomal nucleic acid 155 maps within and is processed from an exon of a noncoding ribosomal nucleic acid transcribed from the B-cell Integration Cluster located on chromosome 21. Micro ribosomal nucleic acid 155 is an oncological micro ribosomal nucleic acid with a crucial role in tumor initiation and development of several B-cell malignancies. Micro ribosomal nucleic acid 155 was upregulated in several malignancies compared to nonmalignant controls and overexpression of micro ribosomal nucleic acid 155 was further associated with poor prognosis. Elevated expression of micro ribosomal nucleic acid 155 shows potentiality as a diagnostic and prognostic biomarker in diffuse large B-cell lymphoma and chronic lymphocytic leukemia. Additionally, in vitro and in vivo studies suggest micro ribosomal nucleic acid 155 as an efficient therapeutic target, supporting its oncogenic function. The use of inhibiting anti-micro ribosomal nucleic acid structures indicates promising potential as novel anticancer therapeutics. The search for non-invasive tools for the diagnosis and management of cancer has long been a goal of cancer research that has led to great interest in the field of circulating nucleic acids in plasma and serum.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date December 24, 2019
Est. primary completion date April 24, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Non hodgkin lymphoma patients of any age or sex. - healthy volunteers within the same range of age. Exclusion Criteria: - patients with any other haematological malignancy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
bone marrow puncture and venous blood samples
bone marrow and peripheral blood samples are collected in non hodgkin lymphoma patients
venous blood samples
venous blood samples are collected in healthy voulnteers

Locations

Country Name City State
Egypt AssiutU Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Ekström-Smedby K. Epidemiology and etiology of non-Hodgkin lymphoma--a review. Acta Oncol. 2006;45(3):258-71. Review. — View Citation

Jansson MD, Lund AH. MicroRNA and cancer. Mol Oncol. 2012 Dec;6(6):590-610. doi: 10.1016/j.molonc.2012.09.006. Epub 2012 Oct 9. Review. — View Citation

Nogai H, Dörken B, Lenz G. Pathogenesis of non-Hodgkin's lymphoma. J Clin Oncol. 2011 May 10;29(14):1803-11. doi: 10.1200/JCO.2010.33.3252. Epub 2011 Apr 11. Review. — View Citation

Willis TG, Dyer MJ. The role of immunoglobulin translocations in the pathogenesis of B-cell malignancies. Blood. 2000 Aug 1;96(3):808-22. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary mean difference of micro ribosomal nucleic acid 155 expression levels between samples of both non hodgkin lymphoma patients and healthy controls measuring levels of micro ribosomal nucleic acid 155 in peripheral blood and bone marrow samples of non hodgkin lymphoma patients and in peripheral blood samples of healthy controls 6 months
Secondary Mean difference of levels of expression of micro ribosomal nucleic acid 155 between peripheral blood and bone marrow samples of non hodgkin lymphoma patients measuring levels of expression of micro ribosomal nucleic acid 155 in peripheral blood and bone marrow samples in non hodgkin lymphoma patients 6 months
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