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Clinical Trials/NCT04339517
NCT04339517
Suspended
Not Applicable

Postoperative Identification of Tumor Cells At the Lumpectomy Site of Patients with Early Breast Cancer

ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Enrollment
20
Locations
1
Primary Endpoint
Identification of Persistent Tumor Cells (PTCs)
Status
Suspended
Last Updated
last year

Overview

Brief Summary

For early breast cancer, local surgery followed by breast radiation is a standard local treatment. It has been found that the original primary tumor site, the lumpectomy site, is the commonest location of local relapse. The researchers think that such relapse occurs because of persistent tumor cells (PTCs) at the lumpectomy site even when conventional pathology reports indicate complete resection with clear margins. The researchers propose to analyze the lumpectomy fluid (seroma) of patients who are one to six weeks post-surgery for the presence or absence of tumor cells using new technology. Results of this study may help identify women who may have increased local relapse risk beyond that suggested by conventional pathology and clinical features; it may also help identify women at very low risk of local relapse who could avoid any additional treatment after local surgery.

Registry
clinicaltrials.gov
Start Date
August 17, 2021
End Date
August 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Women with pathologic stage I to IIB invasive mammary breast cancer.
  • Tumor size over 1 cm.
  • Patient age 50 years or younger.
  • Primary tumor non-lobular.
  • Primary tumor non-low grade or Oncotype DX score \>
  • Patient is six weeks or earlier post-lumpectomy.
  • Seroma is clinically palpable and symptomatic causing discomfort and/or swelling of the lumpectomy site OR re-excision of the lumpectomy site is planned.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Identification of Persistent Tumor Cells (PTCs)

Time Frame: Through study completion, an average of 2 years.

5 ml (one teaspoon) of fluid from the breast surgery site will be collected using a needle and syringe. This fluid will be sent to a laboratory in London Health Sciences Centre where it will be tested for the presence of cancer cells.

Study Sites (1)

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