Biomarkers for Breast Cancer Risk in African American Women

March 27, 2020 updated by: National Cancer Institute (NCI)

Epigenetics and Breast Cancer Risk in African American Women

Background:

- At present, women do not have very accurate tests to inform of them of their personal risk of developing breast cancer. More information on the changes associated with both benign and cancerous breast lesions will help develop better risk information. Researchers have been looking at cells found in breast milk to study genetic changes related to breast cancer. However, most of these cell samples have been collected from white women. A new study wants to collect breast milk samples from African American women for further research. Comparing the results of genetic tests will help improve understanding of breast cancer risk in all women.

Objectives:

- To study genetic changes related to breast lesions, including breast cancer, in African American women.

Eligibility:

- African American women at least 18 years of age who are nursing a baby and who either have had or are being considered for a breast biopsy.

Design:

  • Participants will be screened with personal health questions.
  • Participants will receive a box with sterile bottles for milk collection. They will collect two breast milk samples, one from each breast. They will also fill out a questionnaire about their medical history.
  • The box with the samples and the questionnaire will be returned to the clinical center for study.
  • After the box is returned, participants will be asked to provide a copy of the biopsy report for any breast biopsies they have had.
  • There will be a followup phone call every year. Participants will provide health history information. This information will include whether they have been diagnosed with breast cancer in the previous year.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Increasing evidence supports the importance of the role of pregnancy, lactation and post-weaning breast remodeling in the etiology of certain types of early onset aggressive breast cancers, including basal breast cancers, which are difficult to detect and treat and disproportionately affect African American women. Thus, improving methods for detecting or preventing early onset tumors is important from a clinical, public health and racial disparities perspective. Recent evidence indicates that analysis of breast milk during the postpartum period may advance the discovery of mechanisms and biomarkers related to risk of early onset, aggressive tumors. However, developing methods for collecting, processing and testing milk for biomarkers poses challenges.

A research team co-led by Drs. Mark Sherman (NCI/DCEG/HREB) and Kathleen Arcaro (University of Massachusetts) has received an NIH Bench-to-Bedside award for a project entitled, Molecular Epidemiology of Postpartum Involution of the Breast: Development and Demonstration of Tools for Understanding the Postpartum Period in Relation to Risk for Early Onset Breast Cancer. The specific bench objectives of this project include:

  1. To develop improved methods for fractionating breast milk into epithelial cell rich and liquid components
  2. To optimize assays for DNA methylation, proliferation, apoptosis, p16 expression and telomere lengths using epithelial enriched breast milk fractions, and
  3. To develop assays for TGF-beta ligands, prolactin and sex -steroid hormone using liquid milk fractions.

To achieve these objectives, NCI will initially work with fresh specimens that are being prospectively collected under the University of Massachusetts IRB-approved open protocol entitled Epigenetics and Breast Cancer Risk in African American Women , funded by the Avon Foundation for Women. Dr. Arcaro s lab is studying breast cancer risk and promoter hypermethylation in breast cells obtained from the milk of nursing women. They have analyzed breast cells from nearly 400 women and are continuing with long-term follow-up. However, the majority of the data has been from White women. Since disease risk factors differ between ethnic groups, it is important to test risk assessment methods on a wide population. The main purpose of this specific UMass study is to extend their findings of breast cancer risk to African American women. They plan to recruit 200 lactating African American women to participate in the breast milk study. This involves collecting questionnaire data, completing methylation analyses for eight genes, archiving milk and the remaining DNA for future studies, and annual follow-up.

The key aims that we seek to address through the current protocol are related to objective (1) listed above: To develop improved methods for fractionating breast milk into epithelial cell rich and liquid components. Given that Dr. Arcaro has an IRB approved open protocol to collect fresh milk at University of Massachusetts, NCI can only pursue this collaborative aim (effectively within the timeframe of the bench-to-bedside award) in the context of this ongoing study. Specifically, the collaborative project that is the subject of this IRB application will assess the following aims through in vitro manipulation of fresh liquid milk collections: 1) the effects of modifying the initial rinse of epithelial pellets (rinse solution: saline vs. media; centrifugation speeds, temperature); 2) yields of cells and nucleic acids achievable via fractionation of milk using different types of immunomagnetic beads (coated with antibodies to remove leukocytes ( negative selection ) vs. coated with antibodies to remove epithelial cells ( positive selection ); 3) the relative preservation at room temperature at 24, 48 and 72 hours of milk suspended in cellular fixatives (e.g. formalin, Proclin) as compared to fresh milk without fixation; 4) the possibility that strategies 1 and 2 be combined. This project brings together specific experience and expertise at University of Massachusetts with regard to milk processing with technical knowledge from NCI, provided by Drs. Kopp, Heckman, Yang and Sherman. In particular, NCI Frederick and Dr. Heckman have successfully used immunomagnetic bead technology to purify epithelial cells from blood products and lactating mouse glands by removing leukocytes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

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
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655-0331
        • University of Massachusetts

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Volunteer milk donors (lactating women)

Description

  • INCLUSION CRITERIA:
  • Any woman who identifies as African American, Black, or African
  • Currently nursing a baby
  • Able and willing to sign written informed consent
  • Willing to be contacted by study personnel for follow-up to determine whether a biopsy took place
  • Willing to have her milk sample archived for future analyses

EXCLUSION CRITERIA:

  • The woman does not consider herself to be of African American, Black, or African. These women may participate in the other ongoing Breast Milk Study at University of Massachusetts.
  • Unable to sign written Informed Consent or Assent Form.
  • Unwilling to be contacted by study personnel.

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Volunteers
Volunteer milk donors

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
breast cancer biomarkers
Time Frame: various time points throughout study conduct
breast cancer risk
various time points throughout study conduct

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 999912132
  • 12-C-N132

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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