Breast CancerNCT00900367
Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women
An observational study of Breast Cancer, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 120 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- high performance liquid chromatography, laboratory biomarker analysis and spectroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, 02115
About this study
Official title: Nutrition Modulated Metabolism as a Disease Risk Factor
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- high performance liquid chromatography, laboratory biomarker analysis, spectroscopy
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high performance liquid chromatographyOther
laboratory biomarker analysisOther
spectroscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of metabolome profiles that reflect nutritional status
Measured: ongoing
Utility of rat metabolome profiles for human epidemiological studies
Measured: ongoing
Utility of metabolome profiles in predicting relative risk of developing breast cancer
Measured: ongoing
Identification of critical serum metabolites
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJul 2005
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bruce Kristal, Brigham and Women's Hospital
- Investigators
- Bruce S. Kristal, PhD, Study chair, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900367
- Sponsor's protocol ID
- CDR0000583255
- Other IDs
- BWH-BRC322, R01CA102536
- Status last verified
- Aug 2019
- First submitted
- 9 May 2009
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Modulated Metabolism as a Disease Risk Factor
- ClinicalTrials.gov ID
- NCT00900367
- Acronym / sponsor ID
- CDR0000583255
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2005
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- Up to 120 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women enrolled in the NHS I study; Group selected by Drs. Willett and Hankinson
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high performance liquid chromatography | Other | – |
| laboratory biomarker analysis | Other | – |
| spectroscopy | Procedure or surgery | – |
Primary outcome
Generation of metabolome profiles that reflect nutritional status
Time frame: ongoing
Utility of rat metabolome profiles for human epidemiological studies
Time frame: ongoing
Utility of metabolome profiles in predicting relative risk of developing breast cancer
Time frame: ongoing
Identification of critical serum metabolites
Time frame: ongoing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce S. Kristal, PhD study chair
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of metabolome profiles that reflect nutritional status (time frame: ongoing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.