Breast Cancer
Conditions
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.
Interventions
PROCEDUREAspiration of seroma fluid
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).
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed