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Harvest of CTCs From MBC Patients Using the Parsortix™ PC1 System

NCT03427450 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 421

Last updated 2023-06-05

No results posted yet for this study

Summary

The purpose of this clinical study is to demonstrate that the Parsortix™ PC1 system enables the capture and harvest of circulating tumor cells (CTCs) from the peripheral blood of patients with metastatic breast cancer (MBC) and not from healthy volunteers (HVs). The study is also designed to demonstrate that the CTCs harvested by the Parsortix PC1 system from MBC patients can be used effectively for different types of evaluations (e.g. cytopathology, FISH, qPCR, RNAseq, etc.).

This is an investigational study. The Parsortix PC1 system is not FDA approved and is currently being used for research purposes only.

Conditions

  • Healthy Volunteers
  • Breast Cancer, Metastatic

Interventions

DIAGNOSTIC_TEST

Blood draw

Blood collected will be processed on Parsortix PC1 system for capture and harvest of circulating tumor cells to be used in subsequent evaluations.

Sponsors & Collaborators

  • Angle plc

    lead INDUSTRY

Principal Investigators

  • Naoto Ueno, MD, PhD · UT MD Anderson Cancer Center

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2019-05-16
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03427450 on ClinicalTrials.gov