Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women
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|ClinicalTrials.gov 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
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|
- 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|
|Official Title:||Nutrition Modulated Metabolism as a Disease Risk Factor|
|Study Start Date :||July 2005|
|Estimated Primary Completion Date :||December 2013|
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT00900367
|United States, Massachusetts|
|Dana-Farber/Brigham and Women's Cancer Center|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Bruce S. Kristal, PhD||Brigham and Women's Hospital|