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

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04339517
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 60.4
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: Aspiration of seroma fluid	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Postoperative Identification of Tumor Cells at the Lumpectomy Site of Patients With Early Breast Cancer
• Actual Study Start Date: Aug 17, 2021
• Anticipated Primary Completion Date: Aug 30, 2025
• Anticipated Study Completion Date: Aug 30, 2026

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 50 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Regional Cancer Program; Lawson Research Institute	London	Ontario	Canada	N6A 4L6

Sponsors and Collaborators

• Lawson Health Research Institute

Investigators

• Principal Investigator: Francisco Perera, M.D., Lawson Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT04339517
• Other Study ID Numbers: Breast PTC
• First Posted: Apr 9, 2020
• Last Update Posted: Aug 24, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Aug 24, 2021