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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02798341
Other study ID # UPCC 08110
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2012
Est. completion date July 2030

Study information

Verified date July 2023
Source Abramson Cancer Center at Penn Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 4000
Est. completion date July 2030
Est. primary completion date July 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Biospecimen Collection


Locations

Country Name City State
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of biospecimen collected 15 years
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