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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03304171
Other study ID # 1998-453
Secondary ID
Status Completed
Phase N/A
First received October 3, 2017
Last updated October 9, 2017
Start date October 1995
Est. completion date December 31, 2011

Study information

Verified date October 2017
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 96959
Est. completion date December 31, 2011
Est. primary completion date December 31, 2011
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1995-2011
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