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

Not Applicable

Suspended

• Conditions: Breast Cancer

• Registration Number: NCT04339517
• Lead Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-09
• Study Start: 2021-08-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. Women with pathologic stage I to IIB invasive mammary breast cancer.
2. Tumor size over 1 cm.
3. Patient age 50 years or younger.
4. Primary tumor non-lobular.
5. Primary tumor non-low grade or Oncotype DX score > 18.
6. Patient is six weeks or earlier post-lumpectomy.
7. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Identification of Persistent Tumor Cells (PTCs)	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.

Trial Locations

Locations (1)

London Regional Cancer Program; Lawson Research Institute; 🇨🇦 London, Ontario, Canada