NCT04339517Suspended
Postoperative Identification of Tumor Cells At the Lumpectomy Site of Patients with Early Breast Cancer
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Reason given: Low accrual
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 6 Mar 2020
- Start date
- 17 Aug 2021
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Childhood cancers
- NCT number
- NCT04339517
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: - to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Regional Cancer Program; Lawson Research Institute | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.