This trial is active, not recruiting.

Condition breast cancer
Treatments high performance liquid chromatography, laboratory biomarker analysis, spectroscopy
Sponsor Brigham and Women's Hospital
Collaborator National Cancer Institute (NCI)
Start date July 2005
End date December 2013
Trial size 1500 participants
Trial identifier NCT00900367, BWH-BRC322, CDR0000583255, R01CA102536


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort

Primary Outcomes

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

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Nutrition Modulated Metabolism as a Disease Risk Factor
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.