Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Carcinoma in Situ of the Breast Invasive Breast Cancer

Keywords

Breast CancerTumor Tissue CollectionSerum CollectionPlasma CollectionFresh Tissue CollectionFixed Tissue CollectionTranslational ResearchBiospecimen CollectionSurgical ResectionVascular 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 collectionOther: Blood Sample CollectionOther: 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 collectionOther: Blood Sample CollectionOther: Rectal Swab

Interventions

Tissue Sample collectionProcedure

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

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

Blood Sample CollectionOther

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

Thomas Jefferson University
Otherlead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Nicole SimoneCONTACT2159556702 Nicole.Simone@jefferson.edu

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 NeoplasmsBreast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms 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

Actual (reported)

Primary Completion

July 1, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Prospective Breast Cancer Biospecimen Collection

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Group 1: Newly Diagnosed Breast Cancer Patients

Group 2: Patients with Brain Metastases from Primary Breast Cancer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Group 1: Newly Diagnosed Breast Cancer Patients

Group 2: Patients with Brain Metastases from Primary Breast Cancer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations