Non-Hodgkin LymphomaNCT05921812
Biochemical Role of Circulating microRNAs Expression as Diagnostic Markers for Non-Hodgkin's Lymphoma Patients
An observational study of Non-Hodgkin Lymphoma, run by Sohag University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- real time pcr
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Mar 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have newly diagnosed, histo-pathologically proved Non-Hodgkin's lymphoma,aged from 18-75 and healthy control of matched age and sex
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
zeinab M kadry, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Magdy M Amin, Professor
About this study
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).
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- real time pcr
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real time pcrDiagnostic test
evaluate the expression of certain circulating microRNAs by real time pcr
| Study group | Role | What they receive |
|---|---|---|
| control | apparently healthy individuals with no chronic illness Receives: Diagnostic Test: real time pcr | |
| cases | newly diagnosed Non-Hodgkin's lymphoma patients Receives: Diagnostic Test: real time pcr |
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA16-1
quantification of microRNA16-1 by real time PCR in Non-Hodgkin's lymphoma patients
Measured: 6 months
microRNA 21
quantification of microRNA 21 by real time PCR in Non-Hodgkin's lymphoma patients
Measured: 6months
microRNA 155
quantification of microRNA155 by real time PCR in Non-Hodgkin's lymphoma patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Feb 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrouk Mostafa Galal, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921812
- Sponsor's protocol ID
- Soh-Med-23-06-03MS
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26439034Jorgensen 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.
PubMed 32541886Bedewy 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.
PubMed 28148469Fang 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.
PubMed 21987025
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Role of Circulating microRNAs Expression as Diagnostic Markers for Non-Hodgkin's Lymphoma Patients
- ClinicalTrials.gov ID
- NCT05921812
- Acronym / sponsor ID
- Soh-Med-23-06-03MS
- Conditions
- Non-Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Diagnostic Test: real time pcrapparently healthy individuals with no chronic illness |
| cases | – | Diagnostic Test: real time pcrnewly diagnosed Non-Hodgkin's lymphoma patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have newly diagnosed, histo-pathologically proved Non-Hodgkin's lymphoma,aged from 18-75 and healthy control of matched age and sex
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real time pcrevaluate the expression of certain circulating microRNAs by real time pcr | Diagnostic test | cases, control |
Primary outcome
microRNA16-1
Time frame: 6 months
quantification of microRNA16-1 by real time PCR in Non-Hodgkin's lymphoma patients
microRNA 21
Time frame: 6months
quantification of microRNA 21 by real time PCR in Non-Hodgkin's lymphoma patients
microRNA 155
Time frame: 6 months
quantification of microRNA155 by real time PCR in Non-Hodgkin's lymphoma patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 26439034Sun 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.
- Background: PubMed 32541886Jorgensen 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.
- Background: PubMed 28148469Bedewy 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.
- Background: PubMed 21987025Fang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zeinab M kadry, lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin Lymphoma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shrouk M Galal, demonstrator (01117449592, shroukmostafa@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microRNA16-1 (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05921812, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.