NCT00458588

Brief Summary

RATIONALE: The amount and type of fat in the diet may affect hormone levels, bone mineral density, and breast density later in life. This may affect the risk of developing breast cancer. Learning about the long-term effects of diet on hormone levels, bone mineral density, and breast density may help the study of breast cancer in the future. PURPOSE: This clinical trial is studying the long-term effect of adolescent diet on hormones and breast cancer risk in women previously enrolled in the Dietary Intervention Study in Children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

7.1 years

First QC Date

April 9, 2007

Last Update Submit

April 5, 2017

Conditions

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Mean serum progesterone level in women not using hormonal contraceptives

    Day 1 of treatment

Secondary Outcomes (4)

  • Luteal phase serum estradiol level in women not using hormonal contraceptives

    Day 1 of treatment

  • Bone mineral density of women who are not pregnant

    Day 1 of treatment

  • Breast density of women who are not pregnant

    Day 1 of treatment

  • Prevalence of metabolic syndrome

    Day 1 of treatment

Interventions

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adolescent females

DISEASE CHARACTERISTICS: * Previously enrolled on a clinical trial titled, "Dietary Intervention Study in Children" PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118, United States

Location

Maryland Medical Research Institute

Baltimore, Maryland, 21210, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

UMDNJ University Hospital

Newark, New Jersey, 07107, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Publications (6)

  • Jung S, Goloubeva O, Hylton N, Klifa C, LeBlanc E, Shepherd J, Snetselaar L, Van Horn L, Dorgan JF. Intake of dietary carbohydrates in early adulthood and adolescence and breast density among young women. Cancer Causes Control. 2018 Jul;29(7):631-642. doi: 10.1007/s10552-018-1040-1. Epub 2018 May 25.

  • Bertrand KA, Baer HJ, Orav EJ, Klifa C, Kumar A, Hylton NM, LeBlanc ES, Snetselaar LG, Van Horn L, Dorgan JF. Early Life Body Fatness, Serum Anti-Mullerian Hormone, and Breast Density in Young Adult Women. Cancer Epidemiol Biomarkers Prev. 2016 Jul;25(7):1151-7. doi: 10.1158/1055-9965.EPI-16-0185. Epub 2016 May 9.

  • Bertrand KA, Baer HJ, Orav EJ, Klifa C, Shepherd JA, Van Horn L, Snetselaar L, Stevens VJ, Hylton NM, Dorgan JF. Body fatness during childhood and adolescence and breast density in young women: a prospective analysis. Breast Cancer Res. 2015 Jul 16;17(1):95. doi: 10.1186/s13058-015-0601-4.

  • Jung S, Egleston BL, Chandler DW, Van Horn L, Hylton NM, Klifa CC, Lasser NL, LeBlanc ES, Paris K, Shepherd JA, Snetselaar LG, Stanczyk FZ, Stevens VJ, Dorgan JF. Adolescent endogenous sex hormones and breast density in early adulthood. Breast Cancer Res. 2015 Jun 4;17(1):77. doi: 10.1186/s13058-015-0581-4.

  • Jung S, Stanczyk FZ, Egleston BL, Snetselaar LG, Stevens VJ, Shepherd JA, Van Horn L, LeBlanc ES, Paris K, Klifa C, Dorgan JF. Endogenous sex hormones and breast density in young women. Cancer Epidemiol Biomarkers Prev. 2015 Feb;24(2):369-78. doi: 10.1158/1055-9965.EPI-14-0939. Epub 2014 Nov 4.

  • Dorgan JF, Liu L, Barton BA, Deshmukh S, Snetselaar LG, Van Horn L, Stevens VJ, Robson AM, Lasser NL, Himes JH, Shepherd JA, Pourfarzib R, Pettee Gabriel K, Kriska A, Kwiterovich PO Jr. Adolescent diet and metabolic syndrome in young women: results of the Dietary Intervention Study in Children (DISC) follow-up study. J Clin Endocrinol Metab. 2011 Dec;96(12):E1999-2008. doi: 10.1210/jc.2010-2726. Epub 2011 Oct 12.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Absorptiometry, PhotonMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesSpectrum Analysis

Study Officials

  • Joanne Dorgan, PhD, MPH

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2007

First Posted

April 11, 2007

Study Start

September 1, 2006

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations