Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00900367
Recruitment Status : Unknown
Verified February 2013 by Bruce Kristal, Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : February 15, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bruce Kristal, Brigham and Women's Hospital

Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Other: high performance liquid chromatography Other: laboratory biomarker analysis Procedure: spectroscopy

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.

Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Official Title: Nutrition Modulated Metabolism as a Disease Risk Factor
Study Start Date : July 2005
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Generation of metabolome profiles that reflect nutritional status [ Time Frame: ongoing ]
  2. Utility of rat metabolome profiles for human epidemiological studies [ Time Frame: ongoing ]
  3. Utility of metabolome profiles in predicting relative risk of developing breast cancer [ Time Frame: ongoing ]
  4. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Bruce Kristal, Associate Professor, Brigham and Women's Hospital Identifier: NCT00900367     History of Changes
Other Study ID Numbers: CDR0000583255
R01CA102536 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases