NeoplasmsNCT03712488
Differential Expression of CD200 in B-chronic Lymphoproliferative Disorders by Multicolour Flow Cytometry
An observational study of Neoplasms, run by Assiut University.
Trial summary
The investigator's goals in this study are to assess : 1. Differential expression of CD200 by using flow cytometric immune-phenotyping in broad range of patients with B-chronic lymphoproliferative disorders (B-CLPD) 2. Role of CD200 in diagnosis , classification and potential value in differential diagnosis 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms
- What is being tested?
- flowcytometry
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2018to 1 Apr 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All newly diagnosed patients with B-chronic lymphoproliferative disorders
Who may be able to join
- All newly diagnosed patients with B-chronic lymphoproliferative disorders
Who cannot join
- 1) Patient refusal 2) Patients diagnosed T-cell non-hodgkins lymphoma 3) Patients receiving chemo and/or radiotherapy 4) Patients on steroid therapy for any other cause 5) Patients receiving any immunosuppressive drugs
Trial locations and contacts
No sites are listed yet.
About this study
The investigator's goals in this study are to assess :
- Differential expression of CD200 by using flow cytometric immune-phenotyping in broad range of patients with B-chronic lymphoproliferative disorders (B-CLPD)
- Role of CD200 in diagnosis , classification and potential value in differential diagnosis
- CD200 expression level at different anatomic sites
Read the detailed description
B-Chronic lymphoproliferative disorders (B-CLPDs) are heterogeneous group of disorders with variable clinical presentations and outcomes. They are classified into : chronic lymphocytic leukaemia (CLL), B-cell prolymphocytic leukaemia (B-PLL), hairy cell leukaemia (HCL), and mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL) and lymphoplasmacytic lymphoma/WaldenstrÖm macroglobulinaemia (LPL/WM) in leukaemia phase.
Characterization of CLPDs by immunophenotyping (IPT) has become an important and widely used method in hematology. Immunophenotyping is indispensable for the diagnosis of B-CLPDs through recognition of restricted light chain expression and characteristic phenotypes of separate entities.
Immunophenotypic characterization of lymphoid neoplasms is important for diagnosis, sub-classification, and staging and can also play a role in monitoring minimal residual disease. However, the differential diagnosis may be difficult to resolve in some cases, for example, between B-cell neoplasms with full or partial CD5 expression.
CD200 has recently been identified as a potentially useful antigen for flow cytometric immunophenotyping of lymphoid neoplasms, particularly those of the B lineage.
CD200 belongs to the immunoglobulin superfamily and is composed of a light chain-like structure with two extracellular variable- and constant-like domains followed by a transmembrane segment and a cytoplasmic tail.5 CD200 is expressed by various cell types, including B cells, a subset of T cells (including activated T cells), thymocytes, endothelial cells, and neurons .
CD200 generates an immunosuppressive signal by binding to its cognate receptor, CD200 receptor 1 (CD200R1) , which is expressed specifically in granulocytes and monocytes and in a subset of T cells. CD200 appears to play a role in the regulation of antitumor activity and these findings are the basis for ongoing clinical trials using anti-CD200 therapy for chronic lymphocytic leukemia (CLL)
- Conditions
- Neoplasms
- Being tested
- flowcytometry
- Keywords
- chronic lymphoproliferative disorders
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flowcytometryDevice
four colour flowcytometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential expression of CD200 by using flow cytometric immune-phenotyping in B-chronic lymphoproliferative disorders (B-CLPD)
Analysis of expression of CD200 in B-CLPDs for differential diagnosis of subtypes of B-CLPDs
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start15 Dec 2018 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna-allah M. Atef, Assiut University
- Investigators
- douaa M Sayed, professor, Study director, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712488
- Sponsor's protocol ID
- flow cytometry in neoplasms
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ugo V, Leporrier N, Salaun V, Letestu R, Radford-Weiss I, Ramond S, Nataf J, Guesnu M, Picard F, Brouzes C, Perrot JY, Valensi F, Levy V, Ajchenbaum-Cymbalista F, Troussard X. Deciphering leukemic B-cell chronic lymphoproliferative disorders. Leuk Lymphoma. 2006 Oct;47(10):2088-95. doi: 10.1080/10428190600727939.
PubMed 17071481Schlette E, Fu K, Medeiros LJ. CD23 expression in mantle cell lymphoma: clinicopathologic features of 18 cases. Am J Clin Pathol. 2003 Nov;120(5):760-6. doi: 10.1309/XV4A-G7EM-WQU7-ER67.
PubMed 14608904Baseggio L, Traverse-Glehen A, Petinataud F, Callet-Bauchu E, Berger F, Ffrench M, Couris CM, Thieblemont C, Morel D, Coiffier B, Salles G, Felman P. CD5 expression identifies a subset of splenic marginal zone lymphomas with higher lymphocytosis: a clinico-pathological, cytogenetic and molecular study of 24 cases. Haematologica. 2010 Apr;95(4):604-12. doi: 10.3324/haematol.2009.011049. Epub 2009 Dec 16.
PubMed 20015887Challagundla P, Medeiros LJ, Kanagal-Shamanna R, Miranda RN, Jorgensen JL. Differential expression of CD200 in B-cell neoplasms by flow cytometry can assist in diagnosis, subclassification, and bone marrow staging. Am J Clin Pathol. 2014 Dec;142(6):837-44. doi: 10.1309/AJCPBV9ELXC0ECVL.
PubMed 25389338Rygiel TP, Karnam G, Goverse G, van der Marel AP, Greuter MJ, van Schaarenburg RA, Visser WF, Brenkman AB, Molenaar R, Hoek RM, Mebius RE, Meyaard L. CD200-CD200R signaling suppresses anti-tumor responses independently of CD200 expression on the tumor. Oncogene. 2012 Jun 14;31(24):2979-88. doi: 10.1038/onc.2011.477. Epub 2011 Oct 24.
PubMed 22020332
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Expression of CD200 in B-chronic Lymphoproliferative Disorders by Multicolour Flow Cytometry
- ClinicalTrials.gov ID
- NCT03712488
- Acronym / sponsor ID
- flow cytometry in neoplasms
- Conditions
- Neoplasms
- Keywords
- chronic lymphoproliferative disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 19 Oct 2018 (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 investigator's goals in this study are to assess :
- Differential expression of CD200 by using flow cytometric immune-phenotyping in broad range of patients with B-chronic lymphoproliferative disorders (B-CLPD)
- Role of CD200 in diagnosis , classification and potential value in differential diagnosis
- CD200 expression level at different anatomic sites
Detailed description
B-Chronic lymphoproliferative disorders (B-CLPDs) are heterogeneous group of disorders with variable clinical presentations and outcomes. They are classified into : chronic lymphocytic leukaemia (CLL), B-cell prolymphocytic leukaemia (B-PLL), hairy cell leukaemia (HCL), and mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL) and lymphoplasmacytic lymphoma/WaldenstrÖm macroglobulinaemia (LPL/WM) in leukaemia phase.
Characterization of CLPDs by immunophenotyping (IPT) has become an important and widely used method in hematology. Immunophenotyping is indispensable for the diagnosis of B-CLPDs through recognition of restricted light chain expression and characteristic phenotypes of separate entities.
Immunophenotypic characterization of lymphoid neoplasms is important for diagnosis, sub-classification, and staging and can also play a role in monitoring minimal residual disease. However, the differential diagnosis may be difficult to resolve in some cases, for example, between B-cell neoplasms with full or partial CD5 expression.
CD200 has recently been identified as a potentially useful antigen for flow cytometric immunophenotyping of lymphoid neoplasms, particularly those of the B lineage.
CD200 belongs to the immunoglobulin superfamily and is composed of a light chain-like structure with two extracellular variable- and constant-like domains followed by a transmembrane segment and a cytoplasmic tail.5 CD200 is expressed by various cell types, including B cells, a subset of T cells (including activated T cells), thymocytes, endothelial cells, and neurons .
CD200 generates an immunosuppressive signal by binding to its cognate receptor, CD200 receptor 1 (CD200R1) , which is expressed specifically in granulocytes and monocytes and in a subset of T cells. CD200 appears to play a role in the regulation of antitumor activity and these findings are the basis for ongoing clinical trials using anti-CD200 therapy for chronic lymphocytic leukemia (CLL)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All newly diagnosed patients with B-chronic lymphoproliferative disorders
Key inclusion criteria (1 listed)
- All newly diagnosed patients with B-chronic lymphoproliferative disorders
Key exclusion criteria (1 listed)
- 1) Patient refusal 2) Patients diagnosed T-cell non-hodgkins lymphoma 3) Patients receiving chemo and/or radiotherapy 4) Patients on steroid therapy for any other cause 5) Patients receiving any immunosuppressive drugs
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 |
|---|---|---|
| flowcytometryfour colour flowcytometry | Device | – |
Primary outcome
Differential expression of CD200 by using flow cytometric immune-phenotyping in B-chronic lymphoproliferative disorders (B-CLPD)
Time frame: baseline
Analysis of expression of CD200 in B-CLPDs for differential diagnosis of subtypes of B-CLPDs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Background: PubMed 17071481Ugo V, Leporrier N, Salaun V, Letestu R, Radford-Weiss I, Ramond S, Nataf J, Guesnu M, Picard F, Brouzes C, Perrot JY, Valensi F, Levy V, Ajchenbaum-Cymbalista F, Troussard X. Deciphering leukemic B-cell chronic lymphoproliferative disorders. Leuk Lymphoma. 2006 Oct;47(10):2088-95. doi: 10.1080/10428190600727939.
- Background: PubMed 14608904Schlette E, Fu K, Medeiros LJ. CD23 expression in mantle cell lymphoma: clinicopathologic features of 18 cases. Am J Clin Pathol. 2003 Nov;120(5):760-6. doi: 10.1309/XV4A-G7EM-WQU7-ER67.
- Background: PubMed 20015887Baseggio L, Traverse-Glehen A, Petinataud F, Callet-Bauchu E, Berger F, Ffrench M, Couris CM, Thieblemont C, Morel D, Coiffier B, Salles G, Felman P. CD5 expression identifies a subset of splenic marginal zone lymphomas with higher lymphocytosis: a clinico-pathological, cytogenetic and molecular study of 24 cases. Haematologica. 2010 Apr;95(4):604-12. doi: 10.3324/haematol.2009.011049. Epub 2009 Dec 16.
- Background: PubMed 25389338Challagundla P, Medeiros LJ, Kanagal-Shamanna R, Miranda RN, Jorgensen JL. Differential expression of CD200 in B-cell neoplasms by flow cytometry can assist in diagnosis, subclassification, and bone marrow staging. Am J Clin Pathol. 2014 Dec;142(6):837-44. doi: 10.1309/AJCPBV9ELXC0ECVL.
- Background: PubMed 22020332Rygiel TP, Karnam G, Goverse G, van der Marel AP, Greuter MJ, van Schaarenburg RA, Visser WF, Brenkman AB, Molenaar R, Hoek RM, Mebius RE, Meyaard L. CD200-CD200R signaling suppresses anti-tumor responses independently of CD200 expression on the tumor. Oncogene. 2012 Jun 14;31(24):2979-88. doi: 10.1038/onc.2011.477. Epub 2011 Oct 24.
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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.
douaa M Sayed, professor study director
South Egypt Cancer Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, 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 19 Oct 2018. 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 menna M atef, resident (01025536683, menna.abdelaziz9193@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential expression of CD200 by using flow cytometric immune-phenotyping in B-chronic lymphoproliferative disorders (B-CLPD) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03712488, which also lists 5 linked publications.
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 19 Oct 2018.