A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.

NCT01813825 | Unknown

• 1 other identifier: SVMC 104
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases. The data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.

Conditions

This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting.

Keywords

Mammosite

Outcome Measures

Primary Outcomes (1)

• A Single Site Prospective, Non Randomized Study of Partial Breast Intracavitary Brachytherapy Devices To Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities

  The efficacy of the treatment will be measured by using the overall survival. The following endpoints will also be reported and analyzed:Disease Free Survival, Cause Specific Survival, Ipsilateral Breast Failure, Contralateral Breast Failure.

  1-4 weeks

Study Arms (1)

Female >=45 years, negative margins, DCIS

Other: Registry

Interventions

Registry OTHER

Female >=45 years, negative margins, DCIS

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females, with Breast Cancer Tis, T1,N0,M0. Negative Surgival Margens

You may qualify if:

• Be 45 years of age or older
• Be a Tis, T1, N0 M0 - American Joint Committee Classification
• Have negative surgical margins (NSABP definition) after final surgery
• Should have adequate skin spacing between balloon surface and surface of the skin (\>=7mm)
• DCIS

You may not qualify if:

• Be pregnant or breast-feeding.(If appropriate, patient must use birth control during the study)
• Have collagen-vascular disease
• Have extensive intraductal component (Harvard Definition,\>25% DCIS)
• Have infiltrating lobular histology

Sponsors & Collaborators

• St. Vincent's Medical Center: lead

Study Sites (1)

St. Vincent's Medical Center

Bridgeport, Connecticut, 06606, United States

RECRUITING

MeSH Terms

Interventions

Registries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Deborah Fang, MD

  St. Vincent's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Fang, MD

CONTACT

203-576-5085

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: UNKNOWN
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncology

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 19, 2013
• Study Start: November 1, 2004
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

US (1)