Cellular Diagnosis, Chronic Lymphocytic LeukemiaNCT03380299
Association of CD49d and CD44 in CLL Patients and Their Role in Prognosis
An observational study of Cellular Diagnosis, Chronic Lymphocytic Leukemia, run by Assiut University.
Trial summary
The interactions of chronic lymphocytic leukemia cells with the microenvironment in secondary lymphoid tissues and the bone marrow are known to promote CLL cell survival and proliferation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cellular Diagnosis, Chronic Lymphocytic Leukemia
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 14 Jul 2016to 14 Dec 2018
- How long will I take part?
- 5 Months
- 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
- Child, Adult, Older adult
Study population: 30 patients All patients are newly diagnosed as CLL patients with associated malignancies * Clinical history and clinical examination by the physician. * Complete blood picture: on peripheral blood sample. * BM aspiration: allowing diagnosis of the type of leukemia. * Immunophenotyping by flowcytometer: will be done on peripheral blood or bone marrow aspirate specimens for establishing diagnosis of CLL by detecting its markers ( CD5,CD19,CD23) and for detecting membrane expression of CD49d and CD 44
Who may be able to join
- All patients are newly diagnosed as CLL
Who cannot join
- : patients with associated malignancies
About this study
The interactions of chronic lymphocytic leukemia cells with the microenvironment in secondary lymphoid tissues and the bone marrow are known to promote CLL cell survival and proliferation
Read the detailed description
Chronic lymphocytic leukemia (CLL) is the most common type of chronic leukemia, accounting for approximately 40% of all leukemia's and mainly affecting older individuals. As it has a highly variable clinical course, identification of molecular and biological prognostic markers has provided new insights into the risk stratification of patients with CLL .
The interactions of chronic lymphocytic leukemia cells with the microenvironment in secondary lymphoid tissues and the bone marrow are known to promote CLL cell survival and proliferation . CD49d (one of biomarkers) is one of independent prognostic risk parameter in CLL with important roles in shaping these interactions.
CD49d also is one of independent prognostic risk parameters in CLL that predict adverse outcome and linked to processes involved in interaction with the vascular endothelium and/or migration into the extravascular compartments .
The cell-surface glycoprotein CD44 is involved in cell motility, cellular trafficking, and stem cell differentiation . It contributes to the phenotypic hallmarks of many cancers, such as invasiveness, self-renewal, and sustained survival. CD44 transmits both growth and apoptotic signals, a functional duality that is also observed in hematologic malignancies.
CD44 expression in CLL is mediated by the tumor microenvironment. As a coreceptor, CD44 promotes leukemogenesis by regulating stimuli of MCL1 expression. Moreover, CD44 can be addressed therapeutically in CLL by specific antibodies.
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
To what extent the identification of molecular and biological prognostic markers has provided new insights into the risk stratification of patients with CLL .
detecting membrane expression of CD49d and CD 44 and thier role in prognosis of CLL patients.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start14 Jul 2016
- Primary completion14 Sep 2018 (estimated)
- Study completion14 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cellular Diagnosis, Chronic Lymphocytic 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALShymaa faheem solyman ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380299
- Sponsor's protocol ID
- 1700258
- Status last verified
- Dec 2017
- First submitted
- 8 Dec 2017
- Last updated
- 21 Dec 2017
- 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 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of CD49d and CD44 in CLL Patients and Their Role in Prognosis
- ClinicalTrials.gov ID
- NCT03380299
- Acronym / sponsor ID
- 1700258
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 14 Sep 2018 (estimated)
- Study completion
- 14 Dec 2018 (estimated)
- First posted
- 21 Dec 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.
The interactions of chronic lymphocytic leukemia cells with the microenvironment in secondary lymphoid tissues and the bone marrow are known to promote CLL cell survival and proliferation
Detailed description
Chronic lymphocytic leukemia (CLL) is the most common type of chronic leukemia, accounting for approximately 40% of all leukemia's and mainly affecting older individuals. As it has a highly variable clinical course, identification of molecular and biological prognostic markers has provided new insights into the risk stratification of patients with CLL .
The interactions of chronic lymphocytic leukemia cells with the microenvironment in secondary lymphoid tissues and the bone marrow are known to promote CLL cell survival and proliferation . CD49d (one of biomarkers) is one of independent prognostic risk parameter in CLL with important roles in shaping these interactions.
CD49d also is one of independent prognostic risk parameters in CLL that predict adverse outcome and linked to processes involved in interaction with the vascular endothelium and/or migration into the extravascular compartments .
The cell-surface glycoprotein CD44 is involved in cell motility, cellular trafficking, and stem cell differentiation . It contributes to the phenotypic hallmarks of many cancers, such as invasiveness, self-renewal, and sustained survival. CD44 transmits both growth and apoptotic signals, a functional duality that is also observed in hematologic malignancies.
CD44 expression in CLL is mediated by the tumor microenvironment. As a coreceptor, CD44 promotes leukemogenesis by regulating stimuli of MCL1 expression. Moreover, CD44 can be addressed therapeutically in CLL by specific antibodies.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 30 patients All patients are newly diagnosed as CLL patients with associated malignancies * Clinical history and clinical examination by the physician. * Complete blood picture: on peripheral blood sample. * BM aspiration: allowing diagnosis of the type of leukemia. * Immunophenotyping by flowcytometer: will be done on peripheral blood or bone marrow aspirate specimens for establishing diagnosis of CLL by detecting its markers ( CD5,CD19,CD23) and for detecting membrane expression of CD49d and CD 44
Key inclusion criteria (1 listed)
- All patients are newly diagnosed as CLL
Key exclusion criteria (1 listed)
- : patients with associated malignancies
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 what extent the identification of molecular and biological prognostic markers has provided new insights into the risk stratification of patients with CLL .
Time frame: 1 YEAR
detecting membrane expression of CD49d and CD 44 and thier role in prognosis of CLL patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
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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.
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 Cellular Diagnosis, Chronic Lymphocytic 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 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: status not confirmed, as of the sponsor's last update on 21 Dec 2017. 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 what extent the identification of molecular and biological prognostic markers has provided new insights into the risk stratification of patients with CLL . (time frame: 1 YEAR). 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 21 Dec 2017.