Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

NCT00900367 | Unknown

• 3 other identifiers: CDR0000583255BWH-BRC322R01CA102536
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (4)

• Generation of metabolome profiles that reflect nutritional status

  ongoing

• Utility of rat metabolome profiles for human epidemiological studies

  ongoing

• Utility of metabolome profiles in predicting relative risk of developing breast cancer

  ongoing

• Identification of critical serum metabolites

  ongoing

Interventions

high performance liquid chromatography OTHER

laboratory biomarker analysis OTHER

spectroscopy PROCEDURE

Eligibility Criteria

• Age: Up to 120 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women enrolled in the NHS I study; Group selected by Drs. Willett and Hankinson

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, 02115, United States

Location

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chromatography, High Pressure Liquid; Spectrum Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Bruce S. Kristal, PhD

  Brigham and Women's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: July 1, 2005
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

US (1)