Markers for Predicting Risk of Breast Cancer in Women of Different Races

February 21, 2019 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Molecular Markers for Predicting Risk of Developing Breast Cancer in Different Ethnicities

This research is being done to learn more about the risk of developing breast cancer by studying cells from both normal breast tissue and breast cancer tumor tissue. The goal is to study cells, genes, and gene products to help us to learn how to detect cancer in its earliest stages, and if this information may differ in patients with different ethnic backgrounds.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Evidence suggests that, besides reduced access to care, the increase in breast cancer incidence and mortality in AA (African American) compared to EA (European American or Caucasian) women is influenced by the biology of the tumor. Gene methylation changes caused by environmental factors starting at birth is one mechanism through which genetic and non-genetic factors could affect development of breast cancer and which could underlie disparities in aggressiveness. The investigators were the first to show that a panel of genes was hypermethylated specifically in AA-ER-negative tumors in young women in comparison to EA-tumors in women of the same age. Gene promoter methylation is found at low levels in healthy breast tissues from women without cancer. Race and family history of cancer increase the likelihood of these early events. Thus, epigenetic changes may be early events in transformation of breast cells and tumor formation.

This study will enroll women from different ethnic backgrounds undergoing mastectomy in order to collect normal and tumor tissue to study these genetic changes and breast cancer risk.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287-0013
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with a newly diagnosed breast cancer planning planning surgical management with mastectomy.

Description

Inclusion Criteria:

  • Women
  • 18 years and older
  • Histologically proven infiltrating carcinoma of the breast on diagnostic biopsy. NOTE: Individuals planning bilateral mastectomy procedures (for either bilateral cancers or contralateral prophylactic procedures) either at the same time or in the future will be asked to have tissue removed for the study from both breasts.
  • ER-negative, any PR status, and any HER2 status (i.e., ER-, PR any, HER2- or ER-, PR any, HER2+; "triple positive" breast cancers are not eligible).
  • Unresected, untreated breast cancer planning surgical management with mastectomy (with or without axillary nodal evaluation/dissection and/or with any other clinical assessment).
  • Willing and able to sign an informed consent form

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery
Women undergoing mastectomy are eligible for enrollment.
Procedure: Mastectomy
Unilateral breast cancers planning bilateral mastectomy procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Genetic changes in cells taken from the breasts of women undergoing mastectomy
Time Frame: Time of surgery
Time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

United States Department of Defense

Investigators

  • Study Chair: Saraswati Sukumar, Ph.D., SKCCC at Johns Hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1585
  • IRB00059654 (Other Identifier: JHMIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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