Possibility of Using microRNA30a as a Prognostic Marker in Philadelphia Positive Leukemic Patients by Measure Level of microRNA30a in Blood SampleNCT05112653
Value of MicroRNA30a in Philadelphia Positive Leukemic Patients
An observational study of Possibility of Using microRNA30a as a Prognostic Marker in Philadelphia Positive Leukemic Patients by Measure Level of microRNA30a in Blood Sample, run by Assiut University.
Trial summary
The Philadelphia chromosome in leukemogenesis:The truncated chromosome 22 that results from the reciprocal translocation t(9;22)(q34;q11) is known as (Ph) and is a hallmark of (CML). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Possibility of Using microRNA30a as a Prognostic Marker in Philadelphia Positive Leukemic Patients by Measure Level of microRNA30a in Blood Sample
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Dec 2024
- 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 60 years
- All sexes
- Adult
Study population: 70 patients diagnosed as Philadelphia positive leukemic patients(CML, acute lymphoblastic leukemia, and mixed-phenotype acute leukemia).
3 a-Inclusion criteria
1_clinical diagnosis of Philadelphia positive leukemic patients (males and females).
2- Aged from 18- 60 years. 3-All eligible patients presenting at Clinical Haematology Unit Internal Medicine Department.
4- Without contraindication to receive TKIs therapy. 5-Must able to swallow tablet(TKI therapy).
-exclusion criteria
- NO bone marrow aspirate and flow cytometry confirm their diagnosis.
- patients who refuse to participate in the study.
About this study
The Philadelphia chromosome in leukemogenesis:The truncated chromosome 22 that results from the reciprocal translocation t(9;22)(q34;q11) is known as (Ph) and is a hallmark of (CML). This aberrant fusion gene encodes the breakpoint cluster region-proto-(BCR-ABL1) oncogenic protein with persistently enhanced tyrosine kinase activity. Besides CML, the Ph is found in acute lymphoblastic leukemia, and mixed-phenotype acute leukemia.
Chronic myeloid leukemia is a myeloproliferative neoplasm, characterized by the unrestrained expansion of pluripotent bone marrow stem cells.The hallmark of the disease is the presence of a reciprocal t(9;22)(q34;q11.2), resulting in a derivative 9q+ and a small 22q-. The latter, known as the Philadelphia chromosome, results in a BCR-ABL fusion gene . The diagnosis requires fluorescent in situ hybridization (to demonstrate the BCR-ABL fusion gene or(PCR) to demonstrate the BCR-ABL mRNA transcript.
Read the detailed description
our study will discuss the possible value of microRNA30a as early predictor for TKIs resistance in newly diagnosed CML patients.
the study will dectect the possible value of microRNA30a as prognostic marker in Philadelphia positive acute leukemic patients(ALL, mixed-phenotype acute leukemia) on TKI therapy by assessment level of microRNA30a inpatients who achieved complete hematological remission(CHR) and who failed to achieve CHR.
The study goal has been taken through the role of microRNA30a in reducing ABL1 and BCR-ABL1 protein expression and microRNAs are capable of changing the levels of several key proteins at various steps of the autophagic pathway.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Group of Philadelphia positive leukemic patients will included in the study who divide into: * patient newly diagnosed CML treated with first line of tyrosine kinase inhibitors therapy. * Philadelphia positive acute leukemic patients(ALL, mixed-phenotype acute leukemia) on TKI therapy who achieved complete hematological remission(CHR) and who failed to achieve CHR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect the possibility of using microRNA30a as a prognostic marker in Philadelphia Positive Leukemic Patients by measure level of microRNA30a in blood sample of Philadelphia positive leukemic patients on tyrosine kinase inhibitor therapy
The study goal has been taken through the role of microRNA30a in reducing ABL1 and BCR-ABL1 protein expression and microRNAs are capable of changing the levels of several key proteins at various steps of the autophagic pathway.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Apr 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Possibility of Using microRNA30a as a Prognostic Marker in Philadelphia Positive Leukemic Patients by Measure Level of microRNA30a in Blood SampleStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112653
- Sponsor's protocol ID
- AssiutU2021
- Status last verified
- Nov 2021
- First submitted
- 10 Jul 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of MicroRNA30a in Philadelphia Positive Leukemic Patients
- ClinicalTrials.gov ID
- NCT05112653
- Acronym / sponsor ID
- AssiutU2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Nov 2021 (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.
The Philadelphia chromosome in leukemogenesis:The truncated chromosome 22 that results from the reciprocal translocation t(9;22)(q34;q11) is known as (Ph) and is a hallmark of (CML). This aberrant fusion gene encodes the breakpoint cluster region-proto-(BCR-ABL1) oncogenic protein with persistently enhanced tyrosine kinase activity. Besides CML, the Ph is found in acute lymphoblastic leukemia, and mixed-phenotype acute leukemia.
Chronic myeloid leukemia is a myeloproliferative neoplasm, characterized by the unrestrained expansion of pluripotent bone marrow stem cells.The hallmark of the disease is the presence of a reciprocal t(9;22)(q34;q11.2), resulting in a derivative 9q+ and a small 22q-. The latter, known as the Philadelphia chromosome, results in a BCR-ABL fusion gene . The diagnosis requires fluorescent in situ hybridization (to demonstrate the BCR-ABL fusion gene or(PCR) to demonstrate the BCR-ABL mRNA transcript.
Detailed description
our study will discuss the possible value of microRNA30a as early predictor for TKIs resistance in newly diagnosed CML patients.
the study will dectect the possible value of microRNA30a as prognostic marker in Philadelphia positive acute leukemic patients(ALL, mixed-phenotype acute leukemia) on TKI therapy by assessment level of microRNA30a inpatients who achieved complete hematological remission(CHR) and who failed to achieve CHR.
The study goal has been taken through the role of microRNA30a in reducing ABL1 and BCR-ABL1 protein expression and microRNAs are capable of changing the levels of several key proteins at various steps of the autophagic pathway.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | – | –Group of Philadelphia positive leukemic patients will included in the study who divide into: * patient newly diagnosed CML treated with first line of tyrosine kinase inhibitors therapy. * Philadelphia positive acute leukemic patients(ALL, mixed-phenotype acute leukemia) on TKI therapy who achieved complete hematological remission(CHR) and who failed to achieve CHR. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- 70 patients diagnosed as Philadelphia positive leukemic patients(CML, acute lymphoblastic leukemia, and mixed-phenotype acute leukemia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To detect the possibility of using microRNA30a as a prognostic marker in Philadelphia Positive Leukemic Patients by measure level of microRNA30a in blood sample of Philadelphia positive leukemic patients on tyrosine kinase inhibitor therapy
Time frame: 2 years
The study goal has been taken through the role of microRNA30a in reducing ABL1 and BCR-ABL1 protein expression and microRNAs are capable of changing the levels of several key proteins at various steps of the autophagic pathway.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Possibility of Using microRNA30a as a Prognostic Marker in Philadelphia Positive Leukemic Patients by Measure Level of microRNA30a in Blood Sample, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
To detect the possibility of using microRNA30a as a prognostic marker in Philadelphia Positive Leukemic Patients by measure level of microRNA30a in blood sample of Philadelphia positive leukemic patients on tyrosine kinase inhibitor therapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2021.