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Biospecimen Collection for Breast Cancer

N/A

Recruiting

Led By Nicole Simone, MD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with carcinoma in situ or invasive breast cancer

Subject must be capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will collect tissue and either blood or a rectal swab from patients who are already scheduled for a standard procedure. There will be no follow-up appointments, but researchers will track the patients' health outcomes.

Who is the study for?

This trial is for adults over 18 with breast cancer, including carcinoma in situ or invasive types, who can consent to participate. They must be scheduled for surgical tumor removal, vascular access device placement before neoadjuvant therapy, or neurosurgical resection of a brain metastasis from primary breast cancer.Check my eligibility

What is being tested?

The study involves collecting tissue during standard surgery, a one-time blood draw, and an optional rectal swab for biome analysis. The follow-up consists only of reviewing medical records to track recurrence, metastases, or death.See study design

What are the potential side effects?

Since the trial involves non-invasive sample collection during procedures patients are already undergoing and chart reviews without additional interventions, there are no direct side effects associated with this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with breast cancer, either non-invasive or invasive.

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I can make my own medical decisions or have someone who can.

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I am having surgery for breast cancer or to prepare for its treatment.

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I am over 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tumor biomarker identification

Secondary outcome measures

Laboratory-based breast cancer tumor genomic profile

Trial Design

1Treatment groups

Experimental Treatment

Group I: Standard of CareExperimental Treatment3 Interventions

patients will have tissue procured after a standard of care procedure, a one time blood draw performed, and optional rectal swab

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,239 Total Patients Enrolled

Nicole Simone, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

4 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

Standard of Care Clinical Trial Eligibility Overview. Trial Name: NCT04074720 — N/A

Breast Carcinoma in Situ Research Study Groups: Standard of Care

Breast Carcinoma in Situ Clinical Trial 2023: Standard of Care Highlights & Side Effects. Trial Name: NCT04074720 — N/A

Standard of Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04074720 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research recruiting test subjects currently?

"This clinical trial is currently recruiting participants, as detailed on the website of clinicaltrials.gov. The initial posting was made in May 2018 and there has been a subsequent update issued this past August."

Answered by AI

What is the aggregate headcount of those engaged in this trial?

"Affirmative. Clinicaltrials.gov states that this study is actively enrolling participants since its initial posting on May 10th, 2018 and its most recent update on August 14th, 2023. 200 individuals are required to be recruited from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prospective Breast Cancer Biospecimen Collection

2018. "Prospective Breast Cancer Biospecimen Collection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04074720.

All > Breast Cancer Baltimore