Evaluation of the Chronic Lymphoproliferative Diseases Limited Panel on the BD FACSLyric™ Flow Cytometer

NCT05032313 | Completed FDA Device

• 1 other identifier: CAS-OFLYRICLB-IVDR
• Study Type: observational
• Target: 371
• Locations: 5 countries
• Sites: 6

Brief Summary

Multi-site, prospective performance study to determine equivalency between the investigational CLPD Limited Panel on the FACSLyric system versus the final clinical diagnosis.

Conditions

Chronic Lymphoproliferative Diseases (CLPD)

Outcome Measures

Primary Outcomes (1)

• Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis

  Determine equivalence between the investigational OneFlow CLPD Limited Panel on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (T-cell, B-cell, and NK-cell) or Abnormal (T-cell or B-cell or NK-cell) phenotype using leftover, hematologically abnormal specimens . Sensitivity and specificity are calculated

  Age of specimen for PB and BM (time of collection to start of first pre-wash): ≤ 24 hours.

Secondary Outcomes (1)

• Comparison between expert analysts' determination of normal and abnormal Peripheral Blood (PB) specimen and final diagnosis

  Age of specimen for PB (time of collection to start of first pre-wash): ≤ 24 hours.

Study Arms (1)

Remnant/ Leftover specimens

Specimens that meet inclusion/exclusions criteria and are leftover from routine flow cytometry testing for hematological disorders.

Diagnostic Test: IUO CLPD Limited Panel

Interventions

IUO CLPD Limited Panel DIAGNOSTIC_TEST

This Investigational Panel , comprised of 2 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of mature lymphocyte populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having Chronic Lymphoproliferative Disease .

Remnant/ Leftover specimens

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A minimum of evaluable 250 remnant/leftover peripheral blood, bone marrow, and lymph node specimens from routine flow cytometry laboratory testing for hematological disorders. Specimens from healthy subjects will be excluded. Specimens are from subjects irrespective of race, gender, and ethnicity. Specimen from subject \>22 years of age .

You may qualify if:

• Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
• Specimen with adequate volume (approximately 300 µL) to complete protocol tests.
• Specimen is leftover PB, BM, or LN from routine flow cytometry laboratory testing for chronic lymphoproliferative disorders, other hematological disorders, non-hematological tumors (e.g., solid tumors), or other non-hematological disorders (non-malignant).
• Specimen from newly diagnosed or relapsed subject.
• Only one type of specimen, either PB, BM, or LN shall be enrolled per given subject.
• Specimen is stored at room temperature, upon receipt by the site.
• PB and BM specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
• LN specimens collected in PBS, culture media (e.g., RPMI-1640), saline, or saline wrapped gauze at the discretion of the Investigator.
• Age of specimen for PB and BM (time of collection to start of first pre-wash): ≤ 24 hours. (Note: No Age of specimen claim is being made for LN)
• Specimens are from subjects irrespective of race, gender, and ethnicity.

You may not qualify if:

• Specimen is from healthy subject.
• Specimen is from subject undergoing any treatment for any form of L\&L.
• Specimen from subject \<22 years of age.
• Specimen is from subject with minimal residual disease (MRD) as determined by the site.
• Specimen is from subject suspected of acute leukemia (e.g., T-ALL, BCP-ALL, AML) or myeloid dysplastic syndrome (MDS).
• Visibly clotted specimen.
• Visibly hemolyzed specimen.
• Frozen specimen.
• Refrigerated specimen.
• Fixed specimen.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (6)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Corepath Laboratories

San Antonio, Texas, 78229, United States

Location

Champalimaud Foundation

Lisbon, Portugal

Location

University of Salamanca

Salamanca, 37007, Spain

Location

Kantonsspital Aarau

Aarau, 5000, Switzerland

Location

Cambridge university hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Study Officials

• Imelda Omana-Zapata, MD, PHD

  Becton, Dickinson and Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: April 26, 2021
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); PT (1); GB (1); CH (1); US (2)