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Surgical Tissue Evaluation for Breast Abnormalities

N/A

Waitlist Available

Led By Faina Nakhlis, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Patients must be women

Patients must be at least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

Study Summary

This trial is testing a surgery to see if cancer is present in patients that have had abnormal growths found in a breast biopsy.

Who is the study for?

This trial is for women diagnosed with flat epithelial atypia or intraductal papilloma without atypia by core needle biopsy. Participants must be over 18, not pregnant or breastfeeding, and have had a BIRADS level 1-4 lesion. They should sign informed consent and join within 100 days post-biopsy.Check my eligibility

What is being tested?

The study tests surgical removal of breast tissue to check for cancer in patients previously identified with certain non-cancerous conditions through biopsy. The excised tissue undergoes detailed pathologic evaluation.See study design

What are the potential side effects?

As this trial involves surgical intervention, potential side effects may include pain, infection risk at the incision site, bleeding, scarring, and possible complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman.

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I am 18 years old or older.

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I had a biopsy because of an unusual image on my scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on local pathology review

Secondary outcome measures

Rate of invasive carcinoma and/or DCIS in patients originally diagnosed with FEA or IPWA on core biopsy, based on central pathology review

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pathologic evaluation of excised tissueExperimental Treatment1 Intervention

Patient diagnosed with intraductal papilloma without atypia (IPWA) or flat epithelial atypia (FEA). -- Pathologic evaluation of excised tissue

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,626 Total Patients Enrolled

Faina Nakhlis, MD4.712 ReviewsPrincipal Investigator - Dana-Farber Cancer Institute

Dana-Farber Cancer Institute

1 Previous Clinical Trials

78 Total Patients Enrolled

5Patient Review

Dr. Nakhlis is a top-tier professional. Not only is she an excellent surgeon, she is kind and compassionate. I feel fortunate to be one of her patients.

Frequently Asked Questions

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

Are enrollments for this clinical experiment still being accepted?

"Clinicaltrials.gov shows that this clinical trial has ceased recruiting patients since the last update on January 28th 2022, despite being published as early as September 1st 2015. However, 57 other trials are actively seeking volunteers at the moment."

Answered by AI

How many sites are conducting this clinical research?

"Subjects are being recruited at the University of North carolina - Hillsborough Campus, Maryland's MedStar Franklin Square Medical Center, Georgetown Univeristy in Middletown NJ, plus an additional 18 medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma and/or DCIS in Patients Diagnosed With Intraductal Papilloma Without Atypia or Flat Epithelial Atypia by Core Needle Biopsy

Faina Nakhlis, MD 2015. "The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma and/or DCIS in Patients Diagnosed With Intraductal Papilloma Without Atypia or Flat Epithelial Atypia by Core Needle Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02489617.