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CompletedNCT03282812Updated Sep 14, 2017

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

An observational study in Breast Cancer, sponsored by American Cancer Society, Inc.. Completed. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-09-14.

Sponsored by American Cancer Society, Inc. · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,547
Ages
50 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer

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In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's enrollment of 1,547 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

American Cancer Society, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
Female

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • blood sample
  • cancer free at blood draw

Exclusion criteria

Exclusion Criteria:

  • unverified breast cancer
  • non-invasive breast cancer
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,547 participants (actual)
Patient registry
No

Groups and cohorts

  • cases
  • controls
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What researchers measure

Primary outcomes

  1. Incident invasive breast cancer

    Identified through medical record or linkage with state cancer registry

    Time frame: Blood draw through June 30, 2011

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Calle EE, Rodriguez C, Jacobs EJ, Almon ML, Chao A, McCullough ML, Feigelson HS, Thun MJ. The American Cancer Society Cancer Prevention Study II Nutrition Cohort: rationale, study design, and baseline characteristics. Cancer. 2002 May 1;94(9):2490-501. doi: 10.1002/cncr.101970. PubMed 12015775 ↗
  • Wang Y, Gapstur SM, Carter BD, Hartman TJ, Stevens VL, Gaudet MM, McCullough ML. Untargeted Metabolomics Identifies Novel Potential Biomarkers of Habitual Food Intake in a Cross-Sectional Study of Postmenopausal Women. J Nutr. 2018 Jun 1;148(6):932-943. doi: 10.1093/jn/nxy027. PubMed 29767735 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 1998 to primary completion in May 2001, 35 months.

Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's 35 months is below that.

Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Sep 14, 2017
StartActual
Jun 1998
Primary completionActual
May 2001
CompletionActual
May 2001
Last update
Sep 14, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03282812
Lead sponsor
American Cancer Society, Inc.
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Jun 1998
Primary completion
May 2001
Completion
May 2001
Last update
Sep 14, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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