NCT04734470

Brief Summary

  1. 1.To study the expression pattern of CD19(cluster of differentiation antigen19) complex in lymphoproliferative disorders and its diagnostic value.
  2. 2.To investigate the biological significance of CD19 complex expression in lymphoproliferative disorders.
  3. 3.To explore the possibility of ectopic expression of CD19 complex in non B-lineage lymphoproliferative disorders.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

January 28, 2021

Last Update Submit

February 2, 2021

Conditions

Lymphoproliferative Disorders

Outcome Measures

Primary Outcomes (1)

  • To study the expression pattern of CD19 complex in lymphoproliferative disorders and its diagnostic value.

    Study of CD19 complex expression pattern in lymphoproliferative disorders by flow cytometry

    Baseline

Interventions

Flow cytometryDIAGNOSTIC_TEST

The study of CD19 complex expression in lymphoproliferative disorders by flowcytometry

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sample size is 92 (46 in each arm) but number of controls will be decreased and number of cases will be increased.

You may qualify if:

  • Patients with acute lymphoproliferative disorders.
  • Patients with chronic lymphoproliferative disorders

You may not qualify if:

  • patients with non lymphoid disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM, Chagorova T, de la Serna J, Dilhuydy MS, Illmer T, Opat S, Owen CJ, Samoylova O, Kreuzer KA, Stilgenbauer S, Dohner H, Langerak AW, Ritgen M, Kneba M, Asikanius E, Humphrey K, Wenger M, Hallek M. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10. doi: 10.1056/NEJMoa1313984. Epub 2014 Jan 8.

    PMID: 24401022BACKGROUND

  • Zavala-Vega S, Palma-Lara I, Ortega-Soto E, Trejo-Solis C, de Arellano IT, Ucharima-Corona LE, Garcia-Chacon G, Ochoa SA, Xicohtencatl-Cortes J, Cruz-Cordova A, Luna-Pineda VM, Jimenez-Hernandez E, Vazquez-Meraz E, Mejia-Arangure JM, Guzman-Bucio S, Rembao-Bojorquez D, Sanchez-Gomez C, Salazar-Garcia M, Arellano-Galindo J. Role of Epstein-Barr Virus in Glioblastoma. Crit Rev Oncog. 2019;24(4):307-338. doi: 10.1615/CritRevOncog.2019032655.

    PMID: 32421988BACKGROUND

  • Vaillant AAJ, Stang CM. Lymphoproliferative Disorders. StatPearls [Internet]: StatPearls Publishing; 2020.

    BACKGROUND

  • Zheng YY, Chen G, Zhou XG, Jin Y, Xie JL, Zhang SH, Zhang YN. [Retrospective analysis of 4 cases of the so-called blastic NK-cell lymphoma, with reference to the 2008 WHO classification of tumours of haematopoietic and lymphoid tissues]. Zhonghua Bing Li Xue Za Zhi. 2010 Sep;39(9):600-5. Chinese.

    PMID: 21092587BACKGROUND

  • Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.

    PMID: 24881631BACKGROUND

  • van Zelm MC, Reisli I. CD19 Deficiency due to Genetic Defects in the CD19 and CD81 Genes. Humoral Primary Immunodeficiencies: Springer; 2019. p. 83-95.

    BACKGROUND

  • Pongas GN, Annunziata CM, Staudt LM. PI3Kdelta inhibition causes feedback activation of PI3Kalpha in the ABC subtype of diffuse large B-cell lymphoma. Oncotarget. 2017 Sep 13;8(47):81794-81802. doi: 10.18632/oncotarget.20864. eCollection 2017 Oct 10.

    PMID: 29137222BACKGROUND

  • Dasgupta S, Dasgupta S, Bandyopadhyay M. Regulatory B cells in infection, inflammation, and autoimmunity. Cell Immunol. 2020 Jun;352:104076. doi: 10.1016/j.cellimm.2020.104076. Epub 2020 Feb 27.

    PMID: 32143836BACKGROUND

  • Feingold JM, Ungar DR. DOSAGE REGIMES FOR THE ADMINISTRATION OF AN ANTI-CD19 ADC. US Patent App. 16/622,649; 2020.

    BACKGROUND

  • Beckwith KA, Byrd JC, Muthusamy N. Tetraspanins as therapeutic targets in hematological malignancy: a concise review. Front Physiol. 2015 Mar 23;6:91. doi: 10.3389/fphys.2015.00091. eCollection 2015.

    PMID: 25852576BACKGROUND

  • Yanez DC, Ross S, Crompton T. The IFITM protein family in adaptive immunity. Immunology. 2020 Apr;159(4):365-372. doi: 10.1111/imm.13163. Epub 2019 Dec 22.

    PMID: 31792954BACKGROUND

  • Carroll MC. The complement system in B cell regulation. Mol Immunol. 2004 Jun;41(2-3):141-6. doi: 10.1016/j.molimm.2004.03.017.

    PMID: 15159059BACKGROUND

  • Tedder TF, Poe JC, Fujimoto M, Haas KM, Sato S. The CD19-CD21 signal transduction complex of B lymphocytes regulates the balance between health and autoimmune disease: systemic sclerosis as a model system. Curr Dir Autoimmun. 2005;8:55-90. doi: 10.1159/000082087.

    PMID: 15564717BACKGROUND

MeSH Terms

Conditions

Lymphoproliferative Disorders

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Mahran Mohamed Hussein, Assistant Lecturer

CONTACT

01028444857Mahran_Morsy@med.aun.edu.eg

Maged Salah Mahmoud, Prof. Dr

CONTACT

01011799677m.mahmoud@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 2, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

February 4, 2021

Record last verified: 2021-02