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Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bruce Kristal, Brigham and Women's Hospital Identifier:
First received: May 9, 2009
Last updated: February 14, 2013
Last verified: February 2013

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.

Condition Intervention
Breast Cancer
Other: high performance liquid chromatography
Other: laboratory biomarker analysis
Procedure: spectroscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Nutrition Modulated Metabolism as a Disease Risk Factor

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

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

Biospecimen Retention:   Samples Without DNA

we have only plasma, NHS has DNA samples.

Study is nested case control, so retrospective with respect to individual inclusion, prospective with respect to sample collected before disease. Enrollment is approximate as it includes samples that will be drpped, eg for QC resons

Enrollment: 1500
Study Start Date: July 2005
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women enrolled in the NHS I study; Group selected by Drs. Willett and Hankinson


  • 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


  • Menopausal status not specified


  • Not specified
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Please refer to this study by its identifier: NCT00900367

United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Cancer Institute (NCI)
Study Chair: Bruce S. Kristal, PhD Brigham and Women's Hospital
  More Information

Responsible Party: Bruce Kristal, Associate Professor, Brigham and Women's Hospital Identifier: NCT00900367     History of Changes
Other Study ID Numbers: CDR0000583255
R01CA102536 ( US NIH Grant/Contract Award Number )
Study First Received: May 9, 2009
Last Updated: February 14, 2013

Keywords provided by Brigham and Women's Hospital:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on April 28, 2017