Prospective Breast Cancer Biospecimen Collection

NCT ID: NCT04074720

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-10
• Study Completion Date: 2028-07-01

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

This is a breast cancer biospecimen and possible metastasis procurement study with the goal of obtaining specimens appropriately for genomic and proteomic analysis. Other than reviewing and signing the consent form by the participants in the study, and the study-specific blood tissue procurement and blood draw (and optional biome specimen), all care and clinical encounters will be as per standard of care. There are four times when tissue may be procured and an optional biome specimen collection depending on the treatment course the treating team decides upon. The technique will be chosen based on physician discretion, patient medical treatment, and patient preference. Treatment regimen will consist of tumor sampling/extraction, one blood draw, optional biome specimen collection, and sample storing. This is a single arm study; all participants will have tissue and blood sample procured for biospecimen analysis and repository. Patients have the option to donate a biome specimen as well. Providing the biome sample is optional and will not influence eligibility to patient participation in this study. There will be no assignment or randomization to different treatment groups.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Tissue Sample collection

Intervention Type: PROCEDURE

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

Blood Sample Collection

Intervention Type: OTHER

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

Rectal Swab

Intervention Type: OTHER

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

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.

Tissue Sample collection

Intervention Type: PROCEDURE

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

Blood Sample Collection

Intervention Type: OTHER

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

Rectal Swab

Intervention Type: OTHER

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

Interventions

Tissue Sample collection

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

Intervention Type: PROCEDURE

Blood Sample Collection

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

Intervention Type: OTHER

Rectal Swab

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Simone, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicole Simone, MD

Role: CONTACT

Nicole.Simone@jefferson.edu

215-955-6702

Facility Contacts

Nicole Simone

Role: primary

Nicole.Simone@jefferson.edu

2159556702

Other Identifiers

JT 8877

Identifier Type: OTHER

Identifier Source: secondary_id

16D.674

Identifier Type: -

Identifier Source: org_study_id