Chronic Lymphocytic LeukemiaNCT05371392
Polymorphism of ITGA4 Gene in Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia, run by Sohag University at 1 site in Egypt.
Trial summary
Chronic lymphocytic leukemia (CLL) is a clonal lymphoproliferative disorder that is characterized by heterogeneous presentation at the clinical and molecular levels. ITGA4 protein has been found to be deregulated in CLL with adverse clinical outcome. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: newly diagnosed patients with Chronic lymphocytic leukemia
Who may be able to join
- Patients with newly diagnosed CLL.
Who cannot join
- ▪ Patients previously diagnosed as CLL and received treatment before.
- Patients with other solid tumors.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag university
Sohag
Amer Ahmed Youssef, 01033000406, Amer_ahmed_post@med.sohag.edu.eg
About this study
Official title: Polymorphism of the ITGA4 Gene (Integrin Subunit Alpha 4) in Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) is a clonal lymphoproliferative disorder that is characterized by heterogeneous presentation at the clinical and molecular levels. ITGA4 protein has been found to be deregulated in CLL with adverse clinical outcome. ITGA4 gene (CD49d) encodes a member of the integrin alpha chain family of proteins and is considered a negative prognosticator in CLL with aggressive course and short time to treatment.
The aim of the study:
is to investigate ITGA4 gene expression pattern in CLL.
- Conditions
- Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
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 |
|---|---|---|
| patient group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ITGA4 gene expression pattern in chronic lymphocytic leukemia
Detection of ITGA4 gene expression in blood samples in patients with chronic lymphocytic leukemia, Briefly, total RNA and genomic DNA extraction from fresh peripheral blood samples by Real-time -RT-polymerase chain reaction system (RT-PCR) will be carried out. Rate of ITGA4 gene expression will be recorded.
Measured: 1 year following the startpoint of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Jul 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amer Ahmed Youssef Abdalkareem, Sohag University
- Investigators
- Amer Ahmed Youssif, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371392
- Sponsor's protocol ID
- soh-med-22-04-21
- Status last verified
- Jun 2024
- First submitted
- 29 Apr 2022
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphism of the ITGA4 Gene (Integrin Subunit Alpha 4) in Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT05371392
- Acronym / sponsor ID
- soh-med-22-04-21
- Conditions
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 12 May 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.
Chronic lymphocytic leukemia (CLL) is a clonal lymphoproliferative disorder that is characterized by heterogeneous presentation at the clinical and molecular levels. ITGA4 protein has been found to be deregulated in CLL with adverse clinical outcome. ITGA4 gene (CD49d) encodes a member of the integrin alpha chain family of proteins and is considered a negative prognosticator in CLL with aggressive course and short time to treatment.
The aim of the study:
is to investigate ITGA4 gene expression pattern in CLL.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | – | – |
| control group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- newly diagnosed patients with Chronic lymphocytic leukemia
Key inclusion criteria (1 listed)
- Patients with newly diagnosed CLL.
Key exclusion criteria (2 listed)
- ▪ Patients previously diagnosed as CLL and received treatment before.
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
ITGA4 gene expression pattern in chronic lymphocytic leukemia
Time frame: 1 year following the startpoint of the study
Detection of ITGA4 gene expression in blood samples in patients with chronic lymphocytic leukemia, Briefly, total RNA and genomic DNA extraction from fresh peripheral blood samples by Real-time -RT-polymerase chain reaction system (RT-PCR) will be carried out. Rate of ITGA4 gene expression will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
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.
Amer Ahmed Youssif principal investigator
Sohag 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 Chronic Lymphocytic 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 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 20 Jun 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 Amer Ahmed Youssif (01033000406 ext. Sohag, Amer_ahmed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ITGA4 gene expression pattern in chronic lymphocytic leukemia (time frame: 1 year following the startpoint of the study). 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 20 Jun 2024.