RECRUITING

Pilot Trial of Preop Partial Radiation in Breast Cancer Patients

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

The purpose of our study is to assess the feasibility of preoperative partial breast (APBI) radiation in breast cancer patients. The primary outcome is the acute wound complication rate. We also aim to evaluate cosmetic outcomes and late toxicities as secondary objectives. Another goal is to examine the histopathology of tumors before and after radiation to assess the response and other immunologic and/or molecular changes to the tumor and its environment elicited by the radiation treatment. We hope that this will guide future trials that could change practice in specific patient subgroups.

Official Title

A Pilot Prospective Trial to Assess the Feasibility of Preoperative Partial Breast Radiation in Breast Cancer Patients

Quick Facts

Study Start:2025-09-02
Study Completion:2028-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07178665

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:50 Years to 90 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

Nisha Ohri, MD
CONTACT
732-235-5203
no150@cinj.rutgers.edu
Christian Misdary
CONTACT
732-735-3626
cm1344@cinj.rutgers.edu

Study Locations (Sites)

RWJBarnabas Health Clara Maas Medical Center
Belleville, New Jersey, 07109
United States
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, 07202
United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, 08690
United States
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302
United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
United States
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, 07740
United States
Jack and Sheryl Morris Cancer Center
New Brunswick, New Jersey, 08901
United States
RWJBarnabas Health Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerset, New Jersey, 08873
United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

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 Date2025-09-02
Study Completion Date2028-06-01

Study Record Updates

Study Start Date2025-09-02
Study Completion Date2028-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Early-stage Breast Cancer
  • Breast Carcinoma
  • DCIS