NCT05032339

Brief Summary

Multi-site, prospective performance study to determine equivalency between the investigational OneFlow PCD panel on the FACSLyric system versus the final clinical diagnosis.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
5 countries

5 active sites

Status
completed

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

Study Start

First participant enrolled

May 4, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

August 27, 2021

Last Update Submit

October 26, 2023

Conditions

Plasma Cell Disorder

Keywords

leukemia & lymphoma

Outcome Measures

Primary Outcomes (1)

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

    Determine equivalence between the investigational OneFlow PCD Panel on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for normal polyclonal plasma cells or abnormal plasma cells using leftover, hematologically abnormal specimens. Sensitivity and specificity will be calculated .

    Age of specimen for Peripheral Blood (PB) andBone Marrow (BM) (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 plasma cell disorders

Diagnostic Test: IUO Plasma Cell Disorders Panel

Interventions

IUO Plasma Cell Disorders PanelDIAGNOSTIC_TEST

This Investigational Panel , comprised of 2 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders.

Remnant/ Leftover specimens

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A minimum of 150 remnant/leftover bone marrow specimens from routine flow cytometry laboratory testing for plasma cell disorders, other hematological disorders, non-hematological tumors, and other hematological disorders (non-malignant). Specimens from healthy subjects will be excluded. At least 75 specimens must have abnormal plasma cells, at least 75 must have normal polyclonal plasma cells. Specimens are from subjects irrespective of race, gender, and ethnicity. Subjects above 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 BM from routine flow cytometry laboratory testing for plasma cell disorders, other hematological disorders, non-hematological tumors, and other hematological disorders (non-malignant).
  • Specimen from a newly diagnosed or relapsed subject.
  • Specimen is stored at room temperature, upon receipt by the site.
  • Age of specimen (time of collection to start of first pre-wash): ≤24 hours.
  • Specimen collected in EDTA (K2 or K3) or heparin (sodium or lithium).
  • Specimens are from subjects irrespective of race, gender, and ethnicity.

You may not qualify if:

  • Specimen from healthy subject.
  • Specimen from subject \<22 years old.
  • Specimen from subject undergoing any treatment for any form of L\&L.
  • Specimen from subject with minimal residual disease (MRD) as determined by site.
  • Visibly clotted specimen.
  • Visibly hemolyzed specimen.
  • Frozen specimen.
  • Refrigerated specimen.
  • Fixed specimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Corepath Laboratories

San Antonio, Texas, 78229, United States

Location

Champalimaud Foundation

Lisbon, Portugal

Location

University of Salamanca

Salamanca, 37007, Spain

Location

Kantonsspital Aarau

Aarau, Switzerland

Location

Cambridge university hospital

Cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms, Plasma CellLeukemiaLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

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

May 4, 2021

Primary Completion

October 25, 2023

Study Completion

October 25, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

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