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Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

Nutrition Modulated Metabolism as a Disease Risk Factor

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00900367
Enrollment
1500
Registered
2009-05-12
Start date
2005-07-31
Completion date
2025-12-31
Last updated
2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer

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.

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.

Interventions

OTHERhigh performance liquid chromatography
OTHERlaboratory biomarker analysis
PROCEDUREspectroscopy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 120 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Generation of metabolome profiles that reflect nutritional statusongoing
Utility of rat metabolome profiles for human epidemiological studiesongoing
Utility of metabolome profiles in predicting relative risk of developing breast cancerongoing
Identification of critical serum metabolitesongoing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026