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Prospective Evaluation of AI R&D Tool for Patient Stratification - MoA Evaluation in Triple Negative Breast Cancer (PEAR-MET)

NCT06182306 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-04-03

No results posted yet for this study

Summary

Pear Bio has developed an organ-on-a-chip device together with a computer vision pipeline through which the response of an individual patient's tumor to different systemic therapy regimens can be tested simultaneously ex vivo. This study will recruit patients with advanced or metastatic triple negative breast cancer who are due to start a clinically-indicated new line of therapy.

The oncologist will be blinded to the response on the Pear Bio tool (the assay will be run in parallel with the patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test against patient outcomes (response, progression-free survival, overall survival)

Conditions

Interventions

PROCEDURE

Biopsy

Patients undergo a biopsy from a lesion, and give 40ml of blood

Sponsors & Collaborators

  • Guys' and St. Thomas Hospital

    collaborator UNKNOWN

  • Barts & The London NHS Trust

    collaborator OTHER

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Nottingham University Hospitals Trust

    collaborator UNKNOWN

  • Hampshire Hospitals NHS Foundation Trust

    collaborator OTHER

  • Ourotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Sheeba Irshad, MD PhD · King's College London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2025-09-30
Completion
2026-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT06182306 on ClinicalTrials.gov