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

NCT ID: NCT02574546

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-01-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

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

Study Groups

Surgery

Women undergoing mastectomy are eligible for enrollment.

Mastectomy

Intervention Type: PROCEDURE

Unilateral breast cancers planning bilateral mastectomy procedures.

Interventions

Mastectomy

Unilateral breast cancers planning bilateral mastectomy procedures.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saraswati Sukumar, Ph.D.

Role: STUDY_CHAIR

SKCCC at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00059654

Identifier Type: OTHER

Identifier Source: secondary_id

J1585

Identifier Type: -

Identifier Source: org_study_id