The Breast Program - Translational Cancer Resource

July 18, 2023 updated by: Abramson Cancer Center at Penn Medicine
TRACR will provide a data/biospecimen repository for translational research to better diagnose, prognose, treat and cure breast cancer (and related diseases/treatment conditions). Patients at the Rowan Breast Center will be consented for donation of blood and if available tumor/healthy/archived tissue. Patients will be consented to give permission to use said specimens for future research and to be contacted in the future about other research participation and additional information.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Breast Cancer

Description

Inclusion Criteria:

  • RBC patients with known invasive cancer pre-surgery (greater or equal to 1.5cm) are given priority in recruitment.
  • RBC patients with known invasive cancer pre-surgery (less then 1.5cm). 3. RBC patients who are postsurgery for invasive breast cancer (performed at UPHS or non-UPHS entities).
  • Patients that are of high risk for breast cancer (family history, known deleterious genetic mutation(s)) seeking a prophylactic mastectomy at the breast clinic.
  • Only persons who can understand and give informed consent will be eligible to participate in this study. Furthermore, no persons belonging to vulnerable populations with as children (below 18 years of age), fetuses, neonates or prisoners will be recruited in this study. Pregnant women, who are pre-surgery and having surgery for clinical reasons, can still be recruited for tissue and blood collection.

Exclusion Criteria:

  • Individual who cannot understand and give informed consent (cognitively impaired persons)
  • Children (below 18 years of age), fetuses and neonates
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of biospecimen collected
Time Frame: 15 years
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Angela DeMichele, MD, Abramson Cancer Center at Penn Medicine

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 Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimated)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • UPCC 08110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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