Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

August 11, 2019 updated by: Bruce Kristal, Brigham and Women's Hospital

Nutrition Modulated Metabolism as a Disease Risk Factor

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about nutrition-related changes that identify biomarkers related to cancer. It may also help doctors predict a woman's risk of developing breast cancer.

PURPOSE: This laboratory study is looking at nutrition-related biomarkers in predicting breast cancer risk in women.

Study Overview

Status

Active, not recruiting

Conditions

Breast Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

To complete characterization of metabolic serotypes based on the metabolome, and to adapt these profiles for human epidemiological studies.
To determine the extent to which metabolic profiles that are reflective of or independent of long-term caloric intake predict breast cancer risk in nested case-control studies.
To identify critical serum metabolites.

OUTLINE: Laboratory studies, including metabolome profiling by high performance liquid chromatography; and small molecule identification by mass spectroscopy, are performed on previously collected blood samples.

Study Type

Observational

Enrollment (Actual)

1500

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
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber/Brigham and Women's Cancer Center

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

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women enrolled in the NHS I study; Group selected by Drs. Willett and Hankinson

Description

DISEASE CHARACTERISTICS:

Meets 1 of the following criteria:
- Confirmed breast cancer that was diagnosed at least 2 years after blood sample collection (case)
  - No prior diagnosis of cancer
- Healthy participant (control)
Enrolled in the Nurses' Health Study
Banked blood samples available
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified

PRIOR CONCURRENT THERAPY:

Not specified

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Generation of metabolome profiles that reflect nutritional status Time Frame: ongoing	ongoing
Utility of rat metabolome profiles for human epidemiological studies Time Frame: ongoing	ongoing
Utility of metabolome profiles in predicting relative risk of developing breast cancer Time Frame: ongoing	ongoing
Identification of critical serum metabolites Time Frame: ongoing	ongoing

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Bruce S. Kristal, PhD, Brigham and Women's Hospital

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

July 1, 2005

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria