BD OneFlow CLPD Panel (BD OneFlow LST, and B-CLPD T1 to T4 Assays) on the BD FACSLyric System.

NCT05557422 | Completed FDA Device

• 1 other identifier: CAS-OFLBT1T4
• Study Type: observational
• Target: 322
• Locations: 5 countries
• Sites: 6

Brief Summary

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

Conditions

Chronic Lymphoproliferative Diseases (CLPD)

Outcome Measures

Primary Outcomes (1)

• Comparison between expert analysis determination for normal and abnormal specimen and final dignosis

  Determine equivalence between the investigational OneFlow CLPD 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.

  Age of Specimen for PB and BM (time of collection to start of first pre-washed) <24 hours

Secondary Outcomes (1)

• Comparison between expert analysis determination for normal and abnormal Peripheral Blood (PB) specimen and final dignosis

  ge of Specimen for PB (time of collection to start of first pre-washed) <24 hours.

Interventions

BD OneFlow LST, and B-CLPD T1 to T4 Assays DIAGNOSTIC_TEST

a panel of fluorochrome-conjugated antibodies for qualitative flow-cytometric immunophenotyping of mature lymphocyte populations on the BD FACSLyric™ flow cytometer with BD FACSuite™ Clinical application.

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 (min 700 µL or more) to complete protocol tests.
• Specimen is leftover PB, BM, or LT from routine flow cytometry laboratory testing for chronic lymphoproliferative disorders, other hematological disorders, non-hematological tumors (e.g., solid tumors), or other hematological disorders (non-malignant).
• Specimen is from subjects previous diagnosed, newly diagnosed and/or relapsed disease.
• Only one type of specimen, either PB, BM, or LT 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).
• LT 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 LT)
• 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 Norht Calolina

Chapel Hill, North Carolina, 27514, United States

Location

CorePATH Laboratories

San Antonio, Texas, 78256, United States

Location

Erasmus Medical Center, Laboratory Medical Immunology, Department of Immunology

Rotterdam, 3015 GD, Netherlands

Location

Champalimaud Foundation

Lisbon, Portugal

Location

University of Salamanca

Salamanca, Spain

Location

Kantonsspital Aarau AG / IfLM

Aarau, Switzerland

Location

Study Officials

• Imelda Omana-Zapata, MD, Ph.D

  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: September 23, 2022
• First Posted: September 28, 2022
• Study Start: October 12, 2022
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

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