NCT01736306

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

7.6 years

First QC Date

November 27, 2012

Last Update Submit

March 27, 2020

Conditions

Breast Cancer

Keywords

Breast CancerBreast MilkEpigenetics

Outcome Measures

Primary Outcomes (1)

  • breast cancer biomarkers

    breast cancer risk

    various time points throughout study conduct

Study Arms (1)

Volunteers

Volunteer milk donors

Eligibility Criteria

Age10 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Volunteer milk donors (lactating women)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts

Worcester, Massachusetts, 01655-0331, United States

Location

Related Publications (1)

  • Murphy J, Sherman ME, Browne EP, Caballero AI, Punska EC, Pfeiffer RM, Yang HP, Lee M, Yang H, Gierach GL, Arcaro KF. Potential of breastmilk analysis to inform early events in breast carcinogenesis: rationale and considerations. Breast Cancer Res Treat. 2016 May;157(1):13-22. doi: 10.1007/s10549-016-3796-x. Epub 2016 Apr 23.

    PMID: 27107568BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gretchen Benson, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

July 23, 2012

Primary Completion

February 20, 2020

Study Completion

March 27, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

US(1)