Non Hodgkin Lymphoma and Acute LeukemiaNCT05477667
Study of Let-7a and miRNA-124 in Cases of Non-Hodgkin's Lymphoma and Acute Leukemia
A study testing real time pcr in people with Non Hodgkin Lymphoma and Acute Leukemia, run by Sohag University at 1 site in Egypt.
Trial summary
MiRNAs are noncoding RNAs (ncRNAs) that drive post-transcriptional negative regulation of gene expression by promoting the degradation or translational blockade of their target mRNAs. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Non Hodgkin Lymphoma and Acute Leukemia
- What is being tested?
- real time pcr
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 30 Apr 2023
- Phase
- Interventional
- 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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- approval to sign an informed written consent,
- patient with NHL and acute leukemia .
Who cannot join
- Refusal to sign an informed written consent,
- patient on chemotherapy
Trial locations and contacts
1 site in 1 country.
rania M bakry, professor contact
About this study
MiRNAs are noncoding RNAs (ncRNAs) that drive post-transcriptional negative regulation of gene expression by promoting the degradation or translational blockade of their target mRNAs. MiRNAs are 21-24-nucleotide-long RNA molecules that are processed from longer RNA precursors (pri-miRNAs) , and either the 5' or the 3' strand of the mature miRNA duplex is loaded into the Argonaute (AGO) family of proteins to form a miRNA-induced silencing complex (miRISC) When bound to AGO proteins, mature miRNAs destabilize or inhibit the translation of partially complementary target mRNAsMiRNA-124 has been shown to be a tumor suppressor, and a decrease in its expression level is typical of tumors of various localization, but there is no evidence of the role of miRNA-124 in the development of NHL . There are a number of studies reflecting the involvement of miRNA-124 in hematopoiesis. Liu et al. showed that miRNA-124 regulates Tip110 that is involved in the differentiation of hematopoietic stem cellsThe let-7 family has been shown to influence the pathogenesis of a variety of hematological malignancies through the changing expression of a number of oncogenic pathways, particularly those related with MYC and that might affect hematopoietic carcinogenesis through the modulation of inflammatory pathways
- Conditions
- Non Hodgkin Lymphoma and Acute Leukemia
- 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
Detection of expressin level of MiRNA-124 and let-7a using real time pcr
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | the patients with non-malignant hematological diseases Receives: Diagnostic Test: real time pcr |
| the cases (A) | Active comparator | NHL . Receives: Diagnostic Test: real time pcr |
| the cases (B) | Active comparator | acute leukemia Receives: Diagnostic Test: real time pcr |
What is being measured
The primary outcome is the main question the study is designed to answer.
MiRNA-124 level
Detection of expressin level of MiRNA-124 IN Non-Hodgkin's Lymphoma and acute leukemia
Measured: 6 months
let-7a level
Detection of expressin level of let-7a IN Non-Hodgkin's Lymphoma and acute leukemia
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 posted28 Jul 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (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 Lymphoma and Acute LeukemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Talal Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477667
- Sponsor's protocol ID
- Soh-Med-22-7-22
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Armitage JO, Gascoyne RD, Lunning MA, Cavalli F. Non-Hodgkin lymphoma. Lancet. 2017 Jul 15;390(10091):298-310. doi: 10.1016/S0140-6736(16)32407-2. Epub 2017 Jan 31.
PubMed 28153383Bedewy 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 28148469Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Fuertes T, Ramiro AR, de Yebenes VG. miRNA-Based Therapies in B Cell Non-Hodgkin Lymphoma. Trends Immunol. 2020 Oct;41(10):932-947. doi: 10.1016/j.it.2020.08.006. Epub 2020 Sep 1.
PubMed 32888820
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Let-7a and miRNA-124 in Cases of Non-Hodgkin's Lymphoma and Acute Leukemia
- ClinicalTrials.gov ID
- NCT05477667
- Acronym / sponsor ID
- Soh-Med-22-7-22
- Conditions
- Non Hodgkin Lymphoma and Acute Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 28 Jul 2022 (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.
MiRNAs are noncoding RNAs (ncRNAs) that drive post-transcriptional negative regulation of gene expression by promoting the degradation or translational blockade of their target mRNAs. MiRNAs are 21-24-nucleotide-long RNA molecules that are processed from longer RNA precursors (pri-miRNAs) , and either the 5' or the 3' strand of the mature miRNA duplex is loaded into the Argonaute (AGO) family of proteins to form a miRNA-induced silencing complex (miRISC) When bound to AGO proteins, mature miRNAs destabilize or inhibit the translation of partially complementary target mRNAsMiRNA-124 has been shown to be a tumor suppressor, and a decrease in its expression level is typical of tumors of various localization, but there is no evidence of the role of miRNA-124 in the development of NHL . There are a number of studies reflecting the involvement of miRNA-124 in hematopoiesis. Liu et al. showed that miRNA-124 regulates Tip110 that is involved in the differentiation of hematopoietic stem cellsThe let-7 family has been shown to influence the pathogenesis of a variety of hematological malignancies through the changing expression of a number of oncogenic pathways, particularly those related with MYC and that might affect hematopoietic carcinogenesis through the modulation of inflammatory pathways
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Diagnostic Test: real time pcrthe patients with non-malignant hematological diseases |
| the cases (A) | Active comparator | Diagnostic Test: real time pcrNHL . |
| the cases (B) | Active comparator | Diagnostic Test: real time pcracute leukemia |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- approval to sign an informed written consent,
- patient with NHL and acute leukemia .
Key exclusion criteria (2 listed)
- Refusal to sign an informed written consent,
- patient on chemotherapy
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 pcrDetection of expressin level of MiRNA-124 and let-7a using real time pcr | Diagnostic test | control group, the cases (A), the cases (B) |
Primary outcome
MiRNA-124 level
Time frame: 6 months
Detection of expressin level of MiRNA-124 IN Non-Hodgkin's Lymphoma and acute leukemia
let-7a level
Time frame: 6 months
Detection of expressin level of let-7a IN Non-Hodgkin's Lymphoma and acute leukemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 28153383Armitage JO, Gascoyne RD, Lunning MA, Cavalli F. Non-Hodgkin lymphoma. Lancet. 2017 Jul 15;390(10091):298-310. doi: 10.1016/S0140-6736(16)32407-2. Epub 2017 Jan 31.
- 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 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 32888820Fuertes T, Ramiro AR, de Yebenes VG. miRNA-Based Therapies in B Cell Non-Hodgkin Lymphoma. Trends Immunol. 2020 Oct;41(10):932-947. doi: 10.1016/j.it.2020.08.006. Epub 2020 Sep 1.
- Individual participant dataSharing planned: Undecided
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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.
rania M bakry, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real time pcr in people with Non Hodgkin Lymphoma and Acute Leukemia, 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 2 inclusion and 2 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 28 Jul 2022. 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 sara t mahmoud, assisstent professor (01024914157, sara.ahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MiRNA-124 level (time frame: 6 months). The study lists 2 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 NCT05477667, 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 28 Jul 2022.