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NCT00900367 Clinical Trial

Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

Breast Cancer Clinical Trial

Official title:
Nutrition Modulated Metabolism as a Disease Risk Factor

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00900367
Other study ID # CDR0000583255
Secondary ID BWH-BRC322R01CA1
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2005
Est. completion date December 31, 2025

Study information
Verified date August 2019
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1500
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A to 120 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• high performance liquid chromatography

• laboratory biomarker analysis

Procedure:
• spectroscopy

Locations
Country Name City State
United States Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Brigham and Women's Hospital National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Generation of metabolome profiles that reflect nutritional status ongoing
Primary Utility of rat metabolome profiles for human epidemiological studies ongoing
Primary Utility of metabolome profiles in predicting relative risk of developing breast cancer ongoing
Primary Identification of critical serum metabolites ongoing
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