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Concordance Between Liquid and Tissue Biopsy

NCT04241237 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2021-09-02

No results posted yet for this study

Summary

Tissue biopsy is a procedure to remove a piece of tissue (sample of cells) from the body to be analyzed in a laboratory, and it is commonly performed to confirm diagnosis of a patient with symptoms of breast cancer recurrence. It may also provide information on tumor markers (hormone receptors, HER2) that can guide treatment decisions. The goal of this study is to determine whether blood tests (which require less-invasive procedures) can be used to confirm diagnosis of suspected recurrent breast cancer (as compared to tissue biopsy).

Investigators plan to investigate blood factors which include circulating tumor cells (CTCs - i.e., cancer cells that can be detected in the blood), circulating tumor DNA (ctDNA - i.e., pieces of DNA from cancer cells that can be found in the blood), as well as other biomarkers. Investigators will conduct this study in 120 participants who present with suspected breast cancer recurrence and symptoms of cancer that has spread to other areas in the body.

Participants will be asked for blood collection within 30 days before tissue biopsy. The tissue will be analysed locally to determine the presence of cancer and the tumor markers listed above. The blood will be processed and stored for analysis of CTCs and ctDNA. If these blood tests show concordance with tissue based tests (presence of cancer cells, hormone receptors \& HER2 status), these tests could be used in future studies to confirm diagnosis using a non-invasive procedure. Also, investigators believe that the results of this study can influence other research of early-stage recurrent breast cancer.

Conditions

  • Breast Neoplasms

Interventions

PROCEDURE

Blood Draw

Blood will be drawn from each patient to check the concordance between liquid and tissue biopsy

Sponsors & Collaborators

  • Epic Sciences

    collaborator INDUSTRY

  • University of Western Ontario, Canada

    collaborator OTHER

  • Lunenfeld Tanenbaum Research Institute

    collaborator OTHER

  • MOUNT SINAI HOSPITAL

    collaborator OTHER

  • Toronto Sunnybrook Regional Cancer Centre

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Ana Lohmann, MD, PhD · London Regional Cancer Program

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Canada

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 NCT04241237 on ClinicalTrials.gov