The Breast Program - Translational Cancer Resource

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02798341
• Collaborator: (none)
• Enrollment: 4,000
• Location: 1
• Anticipated Duration (Months): 216
• Patients Per Site Per Month: 18.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Biospecimen Collection

Study Design

• Study Type: Observational
• Actual Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Breast Program - Translational Cancer Resource
• Actual Study Start Date: Jul 1, 2012
• Anticipated Primary Completion Date: Jul 1, 2028
• Anticipated Study Completion Date: Jul 1, 2030

Outcome Measures

Primary Outcome Measures

1. Number of biospecimen collected [15 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Angela DeMichele, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02798341
• Other Study ID Numbers: UPCC 08110
• First Posted: Jun 14, 2016
• Last Update Posted: Jun 3, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 3, 2022