Hematologic MalignanciesNCT04546945
Aberrant Expression of CD56 in Patients With Hematologic Malignancies.
An observational study of Hematologic Malignancies, run by Asmaa Hassan mohamed Abdel Mawjoud at 2 sites in Egypt.
Trial summary
CD56(cluster of differentiation 56) was found to be ectopically expressed in multiple myeloma . A met analysis indicated that CD56 over expression may be an adverse prognostic factor in AML. To the best of our knowledge, no available data the expression pattern of CD56 in other Hematologic malignancies. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- CD56
- How many people
- 38 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Mar 2027to 30 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with hematologic malignancies Newly diagnosed
Who may be able to join
- Patients with hematologic malignancies.
- Newly diagnosed
Who cannot join
- Patients with hematologic disorders other than hematologic malignancies.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 1 recruiting
- Completed
Assiut University
Asyut
- Recruiting
Assiut university
Asyut
Assiut
About this study
Official title: Resident Doctor at Clinical Pathology Department
CD56(cluster of differentiation 56) was found to be ectopically expressed in multiple myeloma . A met analysis indicated that CD56 over expression may be an adverse prognostic factor in AML. To the best of our knowledge, no available data the expression pattern of CD56 in other Hematologic malignancies. This work is designed to evaluate the expression pattern of CD56 in hematologic malignancies.
Read the detailed description
CD56 is the archetypal phenotypic marker of natural killer cells but can actually be expressed by many more immune cells, including alpha, beta T cells, gamma, delta T cells, dendritic cells, and monocytes. Common to all these CD56 expressing cell types have strong immunostimulatory effector functions, including T helper 1 cytokine production and an efficient cytotoxic capacity. Interestingly, both numerical , functional deficiencies and phenotypic alterations of the CD56 immune cell fraction have been reported in patients with various infectious, autoimmune, or malignant diseases.CD56 is also known as neural cell adhesion molecule (NCAM).
Hematologic malignancies are a heterogeneous group of diseases of diverse incidence, prognosis and etiology that arise from malignant transformation of cells from the bone marrow or the lymphatic system.There are two major groups of Hematologic malignancies according to their cell lineage: Myeloid and lymphoid. Lymphoid neoplasms are a varied group that includes non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), leukemia and multiple myeloma (MM).myeloid neoplasms and acute leukaemia include: Myeloproliferative neoplasms (MPN), Myelodysplastic/myeloproliferative neoplasms (MDS/MPN), Myelodysplastic syndromes (MDS), Acute myeloid leukaemia (AML), Acute leukemias of ambiguous lineage, B-lymphoblastic leukaemia/lymphoma, T-lymphoblastic leukaemia/lymphoma.The exact causes of Hematologic malignancies are still unknown although multiple epidemiological studies have reported an association between the development of Hematologic malignancies and several risk factors. Some factors are well documented to increase the risk of some types of leukaemia such as benzene exposure and ionizing radiation.However, many other factors were observed to have an association with Hematologic malignancies such as age, gender, tobacco smoking , obesity , hepatitis C virus (HCV) infection , family history , and environmental exposure to pesticides but with no clear evidence.
CD56 was found to be ectopically expressed in multiple myeloma. A met analysis indicated that CD56 over expression may be an adverse prognostic factor in AML. To the best of our knowledge, no available data the expression pattern of CD56 in other Hematologic malignancies. This work is designed to evaluate the expression pattern of CD56 in hematologic malignancies.
- Conditions
- Hematologic Malignancies
- Being tested
- CD56
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD56Diagnostic test
detection of CD56 by flow cytometry
| Study group | Role | What they receive |
|---|---|---|
| control cases | normal healthy person Receives: Diagnostic Test: CD56 | |
| Patients | Patients with hematologic malignancies. Newly diagnosed. Receives: Diagnostic Test: CD56 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the Pattern of expression of CD56 in hematologic malignancies.
Expression of aberrant CD56 in hematologic malignancies by flowcytometry. To explore incidence of Expression of aberrant CD56 in hematologic malignancies .
Correlation between this expression and outcome of the patient.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start20 Mar 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- 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
- 38 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Asmaa Hassan mohamed Abdel Mawjoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asmaa Hassan mohamed Abdel Mawjoud, Assiut University
- Investigators
- Maged S Mahmoud, prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546945
- Sponsor's protocol ID
- Asmaa Hassan
- Status last verified
- Mar 2026
- First submitted
- 3 Sep 2020
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resident Doctor at Clinical Pathology Department
- ClinicalTrials.gov ID
- NCT04546945
- Acronym / sponsor ID
- Asmaa Hassan
- Conditions
- Hematologic Malignancies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Asmaa Hassan mohamed Abdel MawjoudUniversity, hospital or other
- Study start
- 20 Mar 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Sep 2020 (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.
CD56(cluster of differentiation 56) was found to be ectopically expressed in multiple myeloma . A met analysis indicated that CD56 over expression may be an adverse prognostic factor in AML. To the best of our knowledge, no available data the expression pattern of CD56 in other Hematologic malignancies. This work is designed to evaluate the expression pattern of CD56 in hematologic malignancies.
Detailed description
CD56 is the archetypal phenotypic marker of natural killer cells but can actually be expressed by many more immune cells, including alpha, beta T cells, gamma, delta T cells, dendritic cells, and monocytes. Common to all these CD56 expressing cell types have strong immunostimulatory effector functions, including T helper 1 cytokine production and an efficient cytotoxic capacity. Interestingly, both numerical , functional deficiencies and phenotypic alterations of the CD56 immune cell fraction have been reported in patients with various infectious, autoimmune, or malignant diseases.CD56 is also known as neural cell adhesion molecule (NCAM).
Hematologic malignancies are a heterogeneous group of diseases of diverse incidence, prognosis and etiology that arise from malignant transformation of cells from the bone marrow or the lymphatic system.There are two major groups of Hematologic malignancies according to their cell lineage: Myeloid and lymphoid. Lymphoid neoplasms are a varied group that includes non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), leukemia and multiple myeloma (MM).myeloid neoplasms and acute leukaemia include: Myeloproliferative neoplasms (MPN), Myelodysplastic/myeloproliferative neoplasms (MDS/MPN), Myelodysplastic syndromes (MDS), Acute myeloid leukaemia (AML), Acute leukemias of ambiguous lineage, B-lymphoblastic leukaemia/lymphoma, T-lymphoblastic leukaemia/lymphoma.The exact causes of Hematologic malignancies are still unknown although multiple epidemiological studies have reported an association between the development of Hematologic malignancies and several risk factors. Some factors are well documented to increase the risk of some types of leukaemia such as benzene exposure and ionizing radiation.However, many other factors were observed to have an association with Hematologic malignancies such as age, gender, tobacco smoking , obesity , hepatitis C virus (HCV) infection , family history , and environmental exposure to pesticides but with no clear evidence.
CD56 was found to be ectopically expressed in multiple myeloma. A met analysis indicated that CD56 over expression may be an adverse prognostic factor in AML. To the best of our knowledge, no available data the expression pattern of CD56 in other Hematologic malignancies. This work is designed to evaluate the expression pattern of CD56 in hematologic malignancies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control cases | – | Diagnostic Test: CD56normal healthy person |
| Patients | – | Diagnostic Test: CD56Patients with hematologic malignancies. Newly diagnosed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hematologic malignancies Newly diagnosed
Key inclusion criteria (2 listed)
- Patients with hematologic malignancies.
- Newly diagnosed
Key exclusion criteria (1 listed)
- Patients with hematologic disorders other than hematologic malignancies.
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 |
|---|---|---|
| CD56detection of CD56 by flow cytometry | Diagnostic test | Patients, control cases |
Primary outcome
To identify the Pattern of expression of CD56 in hematologic malignancies.
Time frame: 1 years
Expression of aberrant CD56 in hematologic malignancies by flowcytometry. To explore incidence of Expression of aberrant CD56 in hematologic malignancies . Correlation between this expression and outcome of the patient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- (1) Kelly-Rogers J, Madrigal-Estebas L, O'Connor T, Doherty DG. Activation-induced expression of CD56 by T cells is associated with a reprogramming of cytolytic activity and cytokine secretion profile in vitro. Hum Immunol (2006)Link provided by the sponsor.
- Roothans D, Smits E, Lion E, Tel J, Anguille S. CD56 marks human dendritic cell subsets with cytotoxic potential. Oncoimmunology (2013)Link provided by the sponsor.
- (3) Van Acker HH, Anguille S, Willemen Y, Van den Bergh JM, Berneman ZN, Lion E, et al. Interleukin-15 enhances the proliferation, stimulatory phenotype, and antitumor effector functions of human gamma delta T cells. J Hematol Oncol (2016)Link provided by the sponsor.
- Heleen H. Van Acker,\* Anna Capsomidis, Evelien L. Smits, and Viggo F. Van Tendeloo ( CD56 in the Immune System: More Than a Marker for Cytotoxicity?) Published 2017 frontiers in immunology.Link provided by the sponsor.
- (6) Sant M, Allemani C, Tereanu C, De Angelis R, Capocaccia R, Visser O, Marcos-Gragera R, Maynadie M, Simonetti A, Lutz JM, et al: Incidence of hematologic malignancies in Europe by morphologic subtype: Results of the HAEMACARE project. Blood.Link provided by the sponsor.
- (8)Vardiman JW, Thiele J, Arber DA, Brunning RD, Borowitz MJ, Porwit A, Harris NL, Le Beau MM, Hellström-Lindberg E, Tefferi A and Bloomfield CD: The 2008 revision of the World Health Organization (WHO)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Maged S Mahmoud, prof study director
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancies, run by Asmaa Hassan mohamed Abdel Mawjoud at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact asmaa H mohamed, R.DR (+201024850070, a94asmaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the Pattern of expression of CD56 in hematologic malignancies. (time frame: 1 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 18 Mar 2026.