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Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bruce Kristal, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00900367
First received: May 9, 2009
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Other: high performance liquid chromatography
Other: laboratory biomarker analysis
Procedure: spectroscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Nutrition Modulated Metabolism as a Disease Risk Factor

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Generation of metabolome profiles that reflect nutritional status [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Utility of rat metabolome profiles for human epidemiological studies [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Utility of metabolome profiles in predicting relative risk of developing breast cancer [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Identification of critical serum metabolites [ Time Frame: ongoing ] [ Designated as safety issue: No ]

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


Enrollment: 1500
Study Start Date: July 2005
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900367

Locations
United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Cancer Institute (NCI)
Investigators
Study Chair: Bruce S. Kristal, PhD Brigham and Women's Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bruce Kristal, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00900367     History of Changes
Other Study ID Numbers: CDR0000583255, BWH-BRC322, R01CA102536
Study First Received: May 9, 2009
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013