Prospective Breast Cancer Biospecimen Collection

Not Applicable

Recruiting

• Conditions: Carcinoma in Situ of the Breast; Breast Cancer; Invasive Breast Cancer
• Interventions: Procedure: Tissue Sample collection; Other: Blood Sample Collection; Other: Rectal Swab

• Registration Number: NCT04074720
• Lead Sponsor: Thomas Jefferson University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-10
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2028-08-11
• Study Completion: 2028-08-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard of Care	Blood Sample Collection	patients will have tissue procured after a standard of care procedure, a one time blood draw performed, and optional rectal swab
Standard of Care	Tissue Sample collection	patients will have tissue procured after a standard of care procedure, a one time blood draw performed, and optional rectal swab
Standard of Care	Rectal Swab	patients will have tissue procured after a standard of care procedure, a one time blood draw performed, and optional rectal swab

Primary Outcome Measures

Name	Time	Method
Tumor biomarker identification	Up to 5 years	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).

Secondary Outcome Measures

Name	Time	Method
Laboratory-based breast cancer tumor genomic profile	Up to 5 years	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.

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States