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

NCT04339517 | Suspended

• 1 other identifier: Breast PTC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Identification of Persistent Tumor Cells (PTCs)

  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.

  Through study completion, an average of 2 years.

Interventions

Aspiration of seroma fluid PROCEDURE

Fluid will be collected from the lumpectomy site of patients between one to six weeks post-surgery and tested for the presence of persistent tumor cells (PTCs).

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 \> 18.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

London Regional Cancer Program; Lawson Research Institute

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Francisco Perera, M.D.

  Lawson Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: April 9, 2020
• Study Start: August 17, 2021
• Primary Completion: August 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

CA (1)