Nutrition-Related Biomarkers in Predicting Breast Cancer... | NCT00900367

Studies
Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

NCT00900367

Sponsor

Brigham and Women's Hospital

Status

Unknown status

Last Update Posted

Aug 13, 2019Actual

Enrollment

1,500Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

high performance liquid chromatography
laboratory biomarker analysis
spectroscopy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BWH-BRC322
R01CA102536	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2019

Last Update Posted Date

Aug 13, 2019Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,500Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruce S. Kristal, PhD	Brigham and Women's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana-Farber/Brigham and Women's Cancer Center		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002851	Chromatography, High Pressure Liquid
D013057	Spectrum Analysis

Ancestor Terms

ID	Term
D002853	Chromatography, Liquid
D002845	Chromatography
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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

Name	Type	Description	Arm Group Labels	Other Names
high performance liquid chromatography	Other
laboratory biomarker analysis	Other
spectroscopy	Procedure