Non Hodgkin LymphomaNCT03185325
Micro Ribosomal Nucleic Acid 155 in Non Hodgkin Lymphoma
An observational study of Non Hodgkin Lymphoma, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- bone marrow puncture and venous blood samples and venous blood samples
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2018to 24 Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Non hodgkin lymphoma patients who are newly diagnosed or relapsed cases and healthy controls who have no other heamatological malignancies
Who may be able to join
- Non hodgkin lymphoma patients of any age or sex.
- healthy volunteers within the same range of age.
Who cannot join
- patients with any other haematological malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- bone marrow puncture and venous blood samples, venous blood samples
- 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.
bone marrow puncture and venous blood samplesOther
bone marrow and peripheral blood samples are collected in non hodgkin lymphoma patients
venous blood samplesOther
venous blood samples are collected in healthy voulnteers
| Study group | Role | What they receive |
|---|---|---|
| Non hodgkin lymphoma patients | bone marrow puncture and venous blood samples Receives: Other: bone marrow puncture and venous blood samples | |
| healthy voulnteers | venous blood samples Receives: Other: venous blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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
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 posted14 Jun 2017
- Study start10 Mar 2018
- Primary completion24 Apr 2019
- Study completion24 Dec 2019
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 Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Narouz, Assiut University
- Investigators
- Merna W Narouz, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185325
- Sponsor's protocol ID
- AssiutUniversity
- Status last verified
- Jan 2020
- First submitted
- 10 Jun 2017
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ekstrom-Smedby K. Epidemiology and etiology of non-Hodgkin lymphoma--a review. Acta Oncol. 2006;45(3):258-71. doi: 10.1080/02841860500531682.
PubMed 16644568Nogai H, Dorken 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.
PubMed 21483013Willis TG, Dyer MJ. The role of immunoglobulin translocations in the pathogenesis of B-cell malignancies. Blood. 2000 Aug 1;96(3):808-22. No abstract available.
PubMed 10910891Jansson 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.
PubMed 23102669
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro Ribosomal Nucleic Acid 155 in Non Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT03185325
- Acronym / sponsor ID
- AssiutUniversity
- Conditions
- Non Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 14 Jun 2017 (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 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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non hodgkin lymphoma patients | – | Other: bone marrow puncture and venous blood samplesbone marrow puncture and venous blood samples |
| healthy voulnteers | – | Other: venous blood samplesvenous blood samples |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Non hodgkin lymphoma patients who are newly diagnosed or relapsed cases and healthy controls who have no other heamatological malignancies
Key inclusion criteria (2 listed)
- Non hodgkin lymphoma patients of any age or sex.
- healthy volunteers within the same range of age.
Key exclusion criteria (1 listed)
- patients with any other haematological malignancy.
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 |
|---|---|---|
| bone marrow puncture and venous blood samplesbone marrow and peripheral blood samples are collected in non hodgkin lymphoma patients | Other | Non hodgkin lymphoma patients |
| venous blood samplesvenous blood samples are collected in healthy voulnteers | Other | healthy voulnteers |
Primary outcome
mean difference of micro ribosomal nucleic acid 155 expression levels between samples of both non hodgkin lymphoma patients and healthy controls
Time frame: 6 months
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
1 secondary outcome
Mean difference of levels of expression of micro ribosomal nucleic acid 155 between peripheral blood and bone marrow samples of non hodgkin lymphoma patients
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 16644568Ekstrom-Smedby K. Epidemiology and etiology of non-Hodgkin lymphoma--a review. Acta Oncol. 2006;45(3):258-71. doi: 10.1080/02841860500531682.
- Background: PubMed 21483013Nogai H, Dorken 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.
- Background: PubMed 10910891Willis TG, Dyer MJ. The role of immunoglobulin translocations in the pathogenesis of B-cell malignancies. Blood. 2000 Aug 1;96(3):808-22. No abstract available.
- Background: PubMed 23102669Jansson 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.
- Individual participant dataSharing planned: No
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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.
Merna W Narouz principal investigator
Assiut University
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 Assiut 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 13 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean difference of micro ribosomal nucleic acid 155 expression levels between samples of both non hodgkin lymphoma patients and healthy controls (time frame: 6 months). 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 NCT03185325, 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 13 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.