Invasive Breast CancerNCT03304171
Overall Diet Quality and Breast Cancer Risk
An observational study of Invasive Breast Cancer and Incident Breast Cancer, run by University of California, Irvine.
Trial summary
The purpose of this study was to examine the relationship between indices of overall diet quality and incident breast cancer risk in a large prospective cohort of women. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Invasive Breast Cancer, Incident Breast Cancer
- How many people
- 96,959 participants
- Where
- No sites listed yet
- Study dates
- Oct 1995to 31 Dec 2011
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: Female participants of the California Teachers Study who met the eligibility criteria. The California Teachers Study is comprised entirely of female participants aged 22-104 years old at enrollment who were current and former public school teachers and administrators and completed a 16-page mailed questionnaire at study entry in 1995-1996. Details of the California Teachers Study (CTS) have been described previously (Bernstein L, et al.; 2002).
Who may be able to join
- Participants with no history of cancer diagnosis prior to baseline.
- Participants with no history of myocardial infarction prior to baseline.
- Participants with no history of stroke prior to baseline.
- Participants with no history of diabetes prior to baseline.
- Participants who are not missing excessive dietary data.
- Participants with energy intake values at ≥1% and ≤99% of the population distribution.
Who cannot join
None listed.
About this study
Official title: Diet Quality Scores and Risk of Incident Breast Cancer in Healthy Women
The purpose of this study was to examine the relationship between indices of overall diet quality and incident breast cancer risk in a large prospective cohort of women.
Read the detailed description
This study examined the role of overall diet quality on the risk of developing invasive breast cancer among 96,959 women in the California Teachers Study, in which 4,826 women were diagnosed with breast cancer during follow-up (1995-2011). Participants' dietary habits were recorded at baseline (1995) using a 103-item Block95 Food Frequency Questionnaire to allow for the assessment of overall diet quality. Specifically, diet quality was characterized by the Alternate Mediterranean Diet (aMED), Alternative Healthy Eating Index-2010 (AHEI-2010), Dietary Approaches to Stop Hypertension (DASH), and Paleolithic Index scores. Associations between diet quality and the risk of developing breast cancer were examined using multivariate Cox proportional hazard regression models to provide hazard ratios and corresponding 95% confidence intervals.
- Conditions
- Invasive Breast Cancer, Incident Breast Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Invasive Breast Cancer
All incident cancer cases were identified through linkage with the California Cancer Registry (CCR) records, which is a population-based cancer registry for California residents.
Measured: 1995-2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study startOct 1995
- Primary completion31 Dec 2011
- Study completion31 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 96,959 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vikram Haridass, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304171
- Sponsor's protocol ID
- 1998-453
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bernstein L, Allen M, Anton-Culver H, Deapen D, Horn-Ross PL, Peel D, Pinder R, Reynolds P, Sullivan-Halley J, West D, Wright W, Ziogas A, Ross RK. High breast cancer incidence rates among California teachers: results from the California Teachers Study (United States). Cancer Causes Control. 2002 Sep;13(7):625-35. doi: 10.1023/a:1019552126105.
PubMed 12296510
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Quality Scores and Risk of Incident Breast Cancer in Healthy Women
- ClinicalTrials.gov ID
- NCT03304171
- Acronym / sponsor ID
- 1998-453
- Conditions
- Invasive Breast Cancer, Incident Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96,959 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Oct 1995 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2011 (actual)
- First posted
- 6 Oct 2017 (actual)
- 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.
The purpose of this study was to examine the relationship between indices of overall diet quality and incident breast cancer risk in a large prospective cohort of women.
Detailed description
This study examined the role of overall diet quality on the risk of developing invasive breast cancer among 96,959 women in the California Teachers Study, in which 4,826 women were diagnosed with breast cancer during follow-up (1995-2011). Participants' dietary habits were recorded at baseline (1995) using a 103-item Block95 Food Frequency Questionnaire to allow for the assessment of overall diet quality. Specifically, diet quality was characterized by the Alternate Mediterranean Diet (aMED), Alternative Healthy Eating Index-2010 (AHEI-2010), Dietary Approaches to Stop Hypertension (DASH), and Paleolithic Index scores. Associations between diet quality and the risk of developing breast cancer were examined using multivariate Cox proportional hazard regression models to provide hazard ratios and corresponding 95% confidence intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Female participants of the California Teachers Study who met the eligibility criteria. The California Teachers Study is comprised entirely of female participants aged 22-104 years old at enrollment who were current and former public school teachers and administrators and completed a 16-page mailed questionnaire at study entry in 1995-1996. Details of the California Teachers Study (CTS) have been described previously (Bernstein L, et al.; 2002).
Key inclusion criteria (6 listed)
- Participants with no history of cancer diagnosis prior to baseline.
- Participants with no history of myocardial infarction prior to baseline.
- Participants with no history of stroke prior to baseline.
- Participants with no history of diabetes prior to baseline.
- Participants who are not missing excessive dietary data.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident Invasive Breast Cancer
Time frame: 1995-2011
All incident cancer cases were identified through linkage with the California Cancer Registry (CCR) records, which is a population-based cancer registry for California residents.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Background: PubMed 12296510Bernstein L, Allen M, Anton-Culver H, Deapen D, Horn-Ross PL, Peel D, Pinder R, Reynolds P, Sullivan-Halley J, West D, Wright W, Ziogas A, Ross RK. High breast cancer incidence rates among California teachers: results from the California Teachers Study (United States). Cancer Causes Control. 2002 Sep;13(7):625-35. doi: 10.1023/a:1019552126105.
- California Teacher Study HomepageLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Breast Cancer and Incident Breast Cancer, run by University of California, Irvine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. 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: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incident Invasive Breast Cancer (time frame: 1995-2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03304171, which also lists 1 linked publication.
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 11 Oct 2017.