Prospective Breast Cancer Biospecimen Collection

Breast Cancer Clinical Trial

Official title:

Prospective Breast Cancer Biospecimen Collection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04074720
• Other study ID #: 16D.674
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2018
• Est. completion date: August 11, 2028

Study information

• Verified date: August 2023
• Source: Thomas Jefferson University
• Contact: Nicole Simone, MD
• Phone: 215-955-6702
• Email: Nicole.Simone[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 11, 2028
• Est. primary completion date: August 11, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults >18 years old at time of consent

• Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf.

• Patients with carcinoma in situ or invasive breast cancer

• Patient must be undergoing one of the following:

• definitive surgical tumor resection for breast cancer OR

• placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer OR

• neurosurgical resection of a brain metastasis from primary breast cancer.

Exclusion Criteria:

• <18 years old

• Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent.

• Active drug/alcohol dependence or abuse history

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma in Situ of the Breast
• Invasive Breast Cancer

Intervention

Procedure:
• Tissue Sample collection
Tissue sample collected following standard of care procedure patient was already scheduled to have

Other:
• Blood Sample Collection
A one time sample of blood will be collected on day of standard of care procedure
• Rectal Swab
optional rectal swab may be collected on day of standard of care procedure

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor biomarker identification	Collected biospecimens will be analyzed using current laboratory techniques to identify the presence of breast cancer biomarkers such as estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2).	Up to 5 years
Secondary	Laboratory-based breast cancer tumor genomic profile	Genomic profile will be based on laboratory analysis of the collected tumor tissue biospecimens to identify how genes interact with the tumor and its environment.	Up to 5 years