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Postoperative Identification of Tumor Cells at the Lumpectomy Site of Patients With Early Breast Cancer

Primary Purpose

Breast Cancer

Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aspiration of seroma fluid
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

undefined - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • London Regional Cancer Program; Lawson Research Institute

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2020
Last Updated
March 16, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04339517
Brief Title
Postoperative Identification of Tumor Cells at the Lumpectomy Site of Patients With Early Breast Cancer
Official Title
Postoperative Identification of Tumor Cells at the Lumpectomy Site of Patients With Early Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
Low accrual
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
August 30, 2025 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Aspiration of seroma fluid
Intervention Description
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).
Primary Outcome Measure Information:
Title
Identification of Persistent Tumor Cells (PTCs)
Description
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.
Time Frame
Through study completion, an average of 2 years.

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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 > 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Perera, M.D.
Organizational Affiliation
Lawson Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Regional Cancer Program; Lawson Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Postoperative Identification of Tumor Cells at the Lumpectomy Site of Patients With Early Breast Cancer

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