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Metabolomics and Breast Cancer Risk in a Nested Case-control Study of the Cancer Prevention Study-II Nutrition Cohort

Cancer Prevention Study-II Nutrition Cohort

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03282812
Enrollment
1547
Registered
2017-09-14
Start date
1998-06-30
Completion date
2001-05-31
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

This study aims to investigate diet, lifestyles, serum metabolomics in relation to breast cancer risk in a nested case-control study including 1,547 postmenopausal women from the Cancer Prevention Study II (CPS-II) Nutrition Cohort. The CPS-II Nutrition Cohort is a prospective cohort study of cancer incidence and mortality among 184,185 men and women, established by the American Cancer Society in 1992. Participants completed a self-administered baseline questionnaire in 1992/1993 including demographic, medical, and lifestyle information. Follow-up questionnaires were sent to living participants in 1997 and every other year to update exposure information and ascertain newly diagnosed cancers. From June 1998 through May 2001, blood specimens were collected from 21,963 women. All participants completed a short questionnaire and provided informed consent at the time of blood draw. Non-fasting whole blood collected from each participant was shipped chilled overnight to a central repository, processed, and frozen in liquid nitrogen at approximately -130 °C for long-term storage. Of the 21,963 women who provided a blood sample, investigators identified 782 postmenopausal women diagnosed with invasive breast cancer between blood draw date and June 2011 who had not been diagnosed with cancer (other than nonmelanoma skin cancer) before blood draw or prior to their breast cancer diagnosis. Controls were 1:1 matched to cases on date of birth, date of blood draw, and race and were cancer free at the date of case diagnosis. Seventeen women who were selected as controls were later diagnosed with breast cancer, at which time they became a case. A total of 1,547 postmenopausal women were included in the breast cancer nested case-control study.

Interventions

None listed

Sponsors

American Cancer Society, Inc.
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum

Inclusion criteria

* blood sample * cancer free at blood draw

Exclusion criteria

* unverified breast cancer * non-invasive breast cancer

Design outcomes

Primary

MeasureTime frameDescription
Incident invasive breast cancerBlood draw through June 30, 2011Identified through medical record or linkage with state cancer registry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026