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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04339517
• Other study ID #: Breast PTC
• Status: Suspended
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: August 30, 2026

Study information

• Verified date: March 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Aspiration 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).

Locations

Country	Name	City	State
Canada	London Regional Cancer Program; Lawson Research Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.