Prospective Breast Cancer Biospecimen Collection

NCT04074720 | Recruiting

• 2 other identifiers: 16D.674JT 8877
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Invasive Breast Cancer; Carcinoma in Situ of the Breast

Keywords

Breast Cancer; Tumor Tissue Collection; Serum Collection; Plasma Collection; Fresh Tissue Collection; Fixed Tissue Collection; Translational Research; Biospecimen Collection; Surgical Resection; Vascular Access Placement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Laboratory-based breast cancer tumor genomic profile

  Up to 5 years

Study Arms (2)

Group 1: Newly Diagnosed Breast Cancer Patients

Tissue will be procured during a standard of care procedure the patient will already have scheduled. 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.

Procedure: Tissue Sample collection; Other: Blood Sample Collection; Other: Rectal Swab

Group 2: Patients with Brain Metastases from Primary Breast Cancer

The brain metastasis specimen experiments will use tissue from 36 patients (12 per subtype: estrogen positive, Her-neu-2 positive, and triple negative). Tissue will be procured during a standard of care procedure the patient will already have scheduled. 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.

Procedure: Tissue Sample collection; Other: Blood Sample Collection; Other: Rectal Swab

Interventions

Tissue Sample collection PROCEDURE

Tissue sample collected following standard of care procedure patient was already scheduled to have

Group 1: Newly Diagnosed Breast Cancer Patients; Group 2: Patients with Brain Metastases from Primary Breast Cancer

Blood Sample Collection OTHER

A one time sample of blood will be collected on day of standard of care procedure

Group 1: Newly Diagnosed Breast Cancer Patients; Group 2: Patients with Brain Metastases from Primary Breast Cancer

Rectal Swab OTHER

optional rectal swab may be collected on day of standard of care procedure

Group 1: Newly Diagnosed Breast Cancer Patients; Group 2: Patients with Brain Metastases from Primary Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years old) with newly diagnosed in situ carcinoma or invasive breast cancer, or patients with primary breast cancer with metastasis to the brain. Up to 200 newly diagnosed breast cancer patients, and 36 patients with brain metastases.

You may qualify if:

• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor and normal adjacent tissue samples will be collected from approximately 200 living patients with breast cancer irrespective of hormone status under the care of TJUH clinicians. Serum will be collected at the same time as serum and adjacent normal so that serum exosomes as well as extracellular matrix influences can be examined.

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Nicole Simone, MD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Simone, MD

CONTACT

215-955-6702; Nicole.Simone@jefferson.edu

Study Design

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

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 30, 2019
• Study Start: May 10, 2018
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

US (1)