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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04339517
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : August 24, 2021
Information provided by (Responsible Party):
Lawson Health Research Institute

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 17, 2021
Estimated Primary Completion Date : August 30, 2025
Estimated Study Completion Date : August 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • 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).

Primary Outcome Measures :
  1. Identification of Persistent Tumor Cells (PTCs) [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04339517

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Contact: Francisco Perera, M.D. 519-685-8650
Contact: Alison Allan 519-685-8500 ext 55090

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Canada, Ontario
London Regional Cancer Program; Lawson Research Institute Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Francisco Perera, FRCPC    591-685-8600 ext 53301   
Contact: Joseph Andrews, M.Sc.    519-685-8600 ext 54513   
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: Francisco Perera, M.D. Lawson Research Institute
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Responsible Party: Lawson Health Research Institute Identifier: NCT04339517    
Other Study ID Numbers: Breast PTC
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases