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

NCT ID: NCT05921812

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-03-01

Brief Summary

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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).

Detailed Description

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Conditions

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Non-Hodgkin Lymphoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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control

apparently healthy individuals with no chronic illness

real time pcr

Intervention Type DIAGNOSTIC_TEST

evaluate the expression of certain circulating microRNAs by real time pcr

cases

newly diagnosed Non-Hodgkin's lymphoma patients

real time pcr

Intervention Type DIAGNOSTIC_TEST

evaluate the expression of certain circulating microRNAs by real time pcr

Interventions

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real time pcr

evaluate the expression of certain circulating microRNAs by real time pcr

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. children below 18 years old or elderly people more than 75 years old
2. patients not newly diagnosed with non-Hodgkin's lymphoma
3. presence of any associated other malignancies than non-Hodgkin's lymphoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Shrouk Mostafa Galal

demonstrator at medical biochemistry department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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shrouk M Galal, demonstrator

Role: CONTACT

01117449592

zeinab M kadry, lecturer

Role: CONTACT

01225960747

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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Sun CM, Luan CF. Overexpression of microRNA-21 in peripheral blood mononuclear cells of patients with B-cell non-Hodgkin's lymphoma is associated with disease stage and treatment outcome. Eur Rev Med Pharmacol Sci. 2015 Sep;19(18):3397-402.

Reference Type BACKGROUND
PMID: 26439034 (View on PubMed)

Jorgensen S, Paulsen IW, Hansen JW, Tholstrup D, Hother C, Sorensen E, Petersen MS, Nielsen KR, Rostgaard K, Larsen MAH, Brown PN, Ralfkiaer E, Homburg KM, Hjalgrim H, Erikstrup C, Ullum H, Troelsen J, Gronbaek K, Pedersen OB. The value of circulating microRNAs for early diagnosis of B-cell lymphoma: A case-control study on historical samples. Sci Rep. 2020 Jun 15;10(1):9637. doi: 10.1038/s41598-020-66062-1.

Reference Type BACKGROUND
PMID: 32541886 (View on PubMed)

Bedewy AML, Elmaghraby SM, Shehata AA, Kandil NS. Prognostic Value of miRNA-155 Expression in B-Cell Non-Hodgkin Lymphoma. Turk J Haematol. 2017 Aug 2;34(3):207-212. doi: 10.4274/tjh.2016.0286. Epub 2017 Feb 1.

Reference Type BACKGROUND
PMID: 28148469 (View on PubMed)

Fang C, Zhu DX, Dong HJ, Zhou ZJ, Wang YH, Liu L, Fan L, Miao KR, Liu P, Xu W, Li JY. Serum microRNAs are promising novel biomarkers for diffuse large B cell lymphoma. Ann Hematol. 2012 Apr;91(4):553-9. doi: 10.1007/s00277-011-1350-9. Epub 2011 Oct 11.

Reference Type BACKGROUND
PMID: 21987025 (View on PubMed)

Other Identifiers

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Soh-Med-23-06-03MS

Identifier Type: -

Identifier Source: org_study_id

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