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NCT Number: NCT05921812

Biochemical Role of Circulating microRNAs Expression as Diagnostic Markers for Non-Hodgkin's Lymphoma Patients

Lymphomas are a fairly common malignancy accounting for approximately half of all newly diagnosed hematological neoplasms, and they comprise the sixth most common group of malignancies worldwide in both men and women, With marked geographic variations and affecting more males than females within the age range of 1 to 85 years but peaking within the second decades of life (Oluwasola AO et al., 2011, Roman E et al., 2011 and Jemal A et al., 2010) . Lymphomas have traditionally been classified as either Hodgkin's lymphoma (HL) or non-Hodgkin's lymphoma (NHL) based on the presence or absence of the Reed-Sternberg (RS) cell on histology. (Fitzmaurice C et al., 2017). Non-Hodgkin's lymphoma (NHLs) comprise a wide class of lymphoid neoplasms that evolve from the clonal expansion of mature B, T and natural killer (NK) cells in different stages of development (Morton, L.M. et al., 2014 and Schmitz R et al., 2009). NHLs are the most prevalent hematopoietic neoplasms, accounting for approximately 4.3% of all cancer diagnoses (Sant, M. et al., 2010) , Of them, B cell NHL accounts for approximately 30% of all lymphoid neoplasms, followed by HL (8%) and T/NK neoplasms (5%) (Morton, L.M. et al., 2006).

MicroRNAs (miRNAs) are a class of small, naturally occurring, noncoding and single-stranded RNA molecules (18, 22 nucleotides) that function as post-transcriptional regulators by directly cleaving target messenger RNA (mRNA) or translational repression (Bartel DP. Et al., 2004). The discovery of miRNA has exposed a new layer of gene expression regulation that affects many physiological and pathological processes of life (Lawrie CH. Et al., 2013).

Many abnormal miRNA expression patterns are found in various human malignancies, and certain miRNAs play roles as oncogenes or tumor suppressors (Ling N et al., 2013). Certain miRNAs have been found to characterize various subtypes of NHL and have important roles in B-cell differentiation and lymphomagenesis (Zhang J et al., 2009, Malumbres R et al., 2009, Basso K et al., 2009 and Auer RL et al., 2011). Recently, many studies had shown that tumor cell-specific miRNAs were detectable in the plasma and serum of patients with cancer. Therefore, miRNAs may be served as good biomarkers for early detection, diagnosis, and follow up of patients with cancer (Cortez MA et al., 2012).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University

Sohag, Egypt

Location status: Recruiting

Location contact

Magdy M Amin, Professor

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • This study will include patients who have newly diagnosed, histo-pathologically proved Non-Hodgkin's lymphoma.
  • Age from 18 to 75 years old.
  • anti-neoplastic treatment naïve patients.
  • No associated other malignancies (neither Synchronous nor metachronous) than Non-Hodgkin's lymphoma.

Exclusion criteria

  • children below 18 years old or elderly people more than 75 years old
  • patients not newly diagnosed with non-Hodgkin's lymphoma
  • presence of any associated other malignancies than non-Hodgkin's lymphoma

Treatment and study plan

real time pcr

Diagnostic Test

evaluate the expression of certain circulating microRNAs by real time pcr

Primary outcomes

  1. microRNA16-1

    Time frame: 6 months

    quantification of microRNA16-1 by real time PCR in Non-Hodgkin's lymphoma patients

  2. microRNA 21

    Time frame: 6months

    quantification of microRNA 21 by real time PCR in Non-Hodgkin's lymphoma patients

  3. microRNA 155

    Time frame: 6 months

    quantification of microRNA155 by real time PCR in Non-Hodgkin's lymphoma patients

Study contacts

Contact information is provided by the study sponsor or research team.

shrouk M Galal, demonstrator

CONTACT

[email protected]

01117449592

zeinab M kadry, lecturer

CONTACT

01225960747

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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