The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04242121|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment|
|Myeloma Multiple||Diagnostic Test: fluorescence flow cytometry|
The presence of circulating plasma cells in patients with multiple myeloma is considered as a marker for highly proliferative disease and associated with a worse prognosis.
Plasma cell counting is conventionally done by means of peripheral blood film morphology using light microscopy. However, this manual method is laborious as well as imprecise due to the low number of cells counted, and inter-observer variability. Flow cytometry with monoclonal antibodies is unsuitable as a screening test. The procedure is not automated, and it is expensive and time consuming. Therefore, new rapid, effective and inexepensive methods are needed for risk-stratification in patients with multiple myeloma.
Automated antibody-synthesizing or secreting cells counting from routine haematology systems (XN-1000/20) without sample preparation and in less than 1 minute will further reduce the workload in haematology laboratories and it can be used for counting circulating plasma cells in peripheral blood in patients with multiple myeloma.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood|
|Actual Study Start Date :||January 15, 2020|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||January 31, 2024|
- Diagnostic Test: fluorescence flow cytometry
Countification of plasma cells by fluorescence flow cytometry (hematology analyzer XN-1000/20)
- Time-to-progression according to circulating plasma cells [ Time Frame: [Time Frame: 3 years] ]Measured by cumulative incidence estimates
- Progression-free survival [ Time Frame: [Time Frame: 3 years] ]Measured by Kaplan-Meier estimates
- Overall survival [ Time Frame: [Time Frame: 3 years] ]Measured by Kaplan-Meier estimates
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242121
|Contact: Pirogova Olga, MD, PhDemail@example.com|
|Boris V Afanasyev, MD, Prof.||Recruiting|
|Saint Petersburg, Russian Federation, 197089|
|Contact: Olga V Pirogova, PhD +79214419016 firstname.lastname@example.org|
|Contact: Ivan S Moiseev, PhD +79217961951 email@example.com|
|Sub-Investigator: Mikhail M Kannunnikov, MD|