RECRUITING

Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.

Official Title

Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

Quick Facts

Study Start:2023-07-17
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05825482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Wendy Catchpole
CONTACT
3303446348
catchpw@ccf.org

Principal Investigator

Andrew Fenton, M.D.
PRINCIPAL_INVESTIGATOR
Cleveland Clinic Akron General, Case Comprehensive Cancer Center

Study Locations (Sites)

Cleveland Clinic Akron General, Case Comprehensive Cancer Center
Akron, Ohio, 44302
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Andrew Fenton, M.D., PRINCIPAL_INVESTIGATOR, Cleveland Clinic Akron General, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-17
Study Completion Date2026-11

Study Record Updates

Study Start Date2023-07-17
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer
  • Savi Scout
  • Shave margin
  • Selective margin
  • Breast-Q

Additional Relevant MeSH Terms

  • Breast Cancer