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

NCT02574546 | Withdrawn

• 2 other identifiers: J1585IRB00059654
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Mastectomy

Outcome Measures

Primary Outcomes (1)

• Genetic changes in cells taken from the breasts of women undergoing mastectomy

  Time of surgery

Study Arms (1)

Surgery

Women undergoing mastectomy are eligible for enrollment.

Procedure: Mastectomy

Interventions

Mastectomy PROCEDURE

Unilateral breast cancers planning bilateral mastectomy procedures.

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Women
• 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

You may not qualify if:

• None.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• United States Department of Defense: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287-0013, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and breast tissue (normal and tumor cells) samples will be collected.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Saraswati Sukumar, Ph.D.

  SKCCC at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 14, 2015
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

US (1)