NCT02798341

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jul 2012Jul 2030

Study Start

First participant enrolled

July 1, 2012

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

16 years

First QC Date

June 9, 2016

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of biospecimen collected

    15 years

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Breast Cancer

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor Tissue Healthy Tissue Buffy Coat DNA Plasma Serum

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Angela DeMichele, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 14, 2016

Study Start

July 1, 2012

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2030

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations