Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

NCT ID: NCT00900367

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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high performance liquid chromatography

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

spectroscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bruce Kristal

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce S. Kristal, PhD

Role: STUDY_CHAIR

Brigham and Women's Hospital

Locations

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Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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BWH-BRC322

Identifier Type: -

Identifier Source: secondary_id

R01CA102536

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000583255

Identifier Type: -

Identifier Source: org_study_id

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