Acute Lymphoid LeukemiaNCT05943093
H19 in Acute Lymphoblastic Leukemia.
An observational study of Acute Lymphoid Leukemia, run by Assiut University.
Trial summary
Study the expression level of H19 gene in the samples from ALL patients by real-time PCR. Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients. Read more about this study
- Who is it for?
- Ages 2 months to 70 years
- Conditions the study is for
- Acute Lymphoid Leukemia
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Aug 2025
- 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 2 months to 70 years
- All sexes
- Child, Adult, Older adult
Study population: newly diagnosed ALL patients
Who may be able to join
- Newly diagnosed ALL patients.
Who cannot join
- 1-Presence of other haematological disorders, history of other malignancies or relapsed ALL.
- 2-Patients under chemotherapy or radiotherapy.
Trial locations and contacts
No sites are listed yet.
Hosney Badrawy Hamed, professor contact
About this study
Official title: Expression of Long Non-Coding RNA H19 in Acute Lymphoblastic Leukemia
- Study the expression level of H19 gene in the samples from ALL patients by real-time PCR.
- Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients.
Read the detailed description
Acute lymphoblastic leukemia (ALL) is the most common cancer affecting children and adolescents (Zeng XL et al, 2023). ALL is a haematological malignancy characterized by the malignant clonal expansion of lymphoid hematopoietic precursors (Hong Z et al, 2021). It arises from B- or T-lineage lymphoid progenitors: B-cell-precursor ALL (B-ALL) and T-cell ALL (T-ALL) (Brady SW et al., 2022). Rrelapse in ALL is the fundamental cause of treatment failure in 15-20% of patients (Hulleman E et al, 2009). Therefore, the exploration of novel functional molecules that play a role in ALL pathogenesis could be effective therapeutic targets for this disease (Asadi M et al, 2023).
Long non-coding RNAs (lncRNAs) are non-protein coding transcripts longer than 200 nucleotides (Kopp F et al, 2018). H19 was the first lncRNA to be discovered and submitted for genomic imprinting (Yoshimura H et al, 2018). It has a role in embryogenesis and tumorigenesis (Yoshimura H et al, 2014). It also has an indispensable role in enhancing cell proliferation, differentiation, migration, invasion, and chemo resistance (Li Y et al, 2020). Recent evidence has shown that H19 is an oncogene and is overexpressed in breast, liver, endometrial, lung, cervical, and esophageal cancers (Asadi M et al, 2023). A similar pattern of H19 expression was observed in various types of leukemias, including chronic myeloid leukemia (CML) (Morlando M et al, 2015) and acute myeloid leukemia (AML) (Zhang Tj et al, 2018).
- Conditions
- Acute Lymphoid Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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 |
|---|---|---|
| ALL patients | Not described | |
| control group free from the disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Study the expression level of H19 gene in the samples from ALL patients by real-time PCR.
Measured: baseline
Secondary outcomes (1)
Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoid LeukemiaStudies 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
- Retrospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Refaat Ibrahim Ismail, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943093
- Sponsor's protocol ID
- PCR in acute leukemia
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Long Non-Coding RNA H19 in Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05943093
- Acronym / sponsor ID
- PCR in acute leukemia
- Conditions
- Acute Lymphoid Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Jul 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.
- Study the expression level of H19 gene in the samples from ALL patients by real-time PCR.
- Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients.
Detailed description
Acute lymphoblastic leukemia (ALL) is the most common cancer affecting children and adolescents (Zeng XL et al, 2023). ALL is a haematological malignancy characterized by the malignant clonal expansion of lymphoid hematopoietic precursors (Hong Z et al, 2021). It arises from B- or T-lineage lymphoid progenitors: B-cell-precursor ALL (B-ALL) and T-cell ALL (T-ALL) (Brady SW et al., 2022). Rrelapse in ALL is the fundamental cause of treatment failure in 15-20% of patients (Hulleman E et al, 2009). Therefore, the exploration of novel functional molecules that play a role in ALL pathogenesis could be effective therapeutic targets for this disease (Asadi M et al, 2023).
Long non-coding RNAs (lncRNAs) are non-protein coding transcripts longer than 200 nucleotides (Kopp F et al, 2018). H19 was the first lncRNA to be discovered and submitted for genomic imprinting (Yoshimura H et al, 2018). It has a role in embryogenesis and tumorigenesis (Yoshimura H et al, 2014). It also has an indispensable role in enhancing cell proliferation, differentiation, migration, invasion, and chemo resistance (Li Y et al, 2020). Recent evidence has shown that H19 is an oncogene and is overexpressed in breast, liver, endometrial, lung, cervical, and esophageal cancers (Asadi M et al, 2023). A similar pattern of H19 expression was observed in various types of leukemias, including chronic myeloid leukemia (CML) (Morlando M et al, 2015) and acute myeloid leukemia (AML) (Zhang Tj et al, 2018).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALL patients | – | – |
| control group free from the disease | – | – |
Who may qualify
- Ages
- 2 months to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- newly diagnosed ALL patients
Key inclusion criteria (1 listed)
- Newly diagnosed ALL patients.
Key exclusion criteria (2 listed)
- 1-Presence of other haematological disorders, history of other malignancies or relapsed ALL.
- 2-Patients under chemotherapy or radiotherapy.
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
- Study the expression level of H19 gene in the samples from ALL patients by real-time PCR.
Time frame: baseline
1 secondary outcome
Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Related InfoLink provided by the sponsor.
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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.
Hosney Badrawy Hamed, professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoid Leukemia, 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?
The sponsor lists 1 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 13 Jul 2023. 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?
Contact Fatma Refaat Ibrahim (01032073035, drfatmarefaat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Study the expression level of H19 gene in the samples from ALL patients by real-time PCR. (time frame: baseline). 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 13 Jul 2023.