NCT00445445

Brief Summary

RATIONALE: Studying mammograms for breast density changes over time may help doctors predict breast cancer risk. PURPOSE: This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

8 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

January 10, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2014

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

7.5 years

First QC Date

March 7, 2007

Last Update Submit

February 10, 2020

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent breast cancerbreast cancer in situ

Outcome Measures

Primary Outcomes (3)

  • Within-individual mammographic density (MD) longitudinal change and breast cancer risk

    cancer cases diagnosed within the last 3 years (2004-2006).

  • Patterns of within-individual longitudinal change in MD

    cancer cases diagnosed within the last 3 years (2004-2006)

  • Predictors of across-individual differences in MD change

    cancer cases diagnosed within the last 3 years (2004-2006)

Study Arms (2)

Patients

Histologically confirmed breast cancer that was diagnosed between the years 2002-2004

Other: physiologic testingOther: screening questionnaire administrationProcedure: breast imaging studyProcedure: radiomammographyProcedure: study of high risk factors

Healthy participants

Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.

Other: physiologic testingOther: screening questionnaire administrationProcedure: breast imaging studyProcedure: radiomammographyProcedure: study of high risk factors

Interventions

physiologic testingOTHER

Urine samples will be assessed for levels of bisphenol-A

Healthy participantsPatients
screening questionnaire administrationOTHER

Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.

Healthy participantsPatients
breast imaging studyPROCEDURE

Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.

Healthy participantsPatients
radiomammographyPROCEDURE

Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.

Healthy participantsPatients
study of high risk factorsPROCEDURE

* Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk. * Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.

Healthy participantsPatients

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Breast cancer cases diagnosed after 1994 and equal number of frequency-matched (by age within 2 years and ethnicity) controls. Cases and eligible controls with at least 3 screening mammograms since 1994 will be recruited through the University Hospitals Breast Center, and primary care clinics within the University Hospitals Health System (UHHS). The restriction of 3 or more screening mammograms will allow us to adequately model the longitudinal change patterns.

You may qualify if:

  • Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system
  • Have at least 3 screening mammograms since 1994
  • for cases, diagnosis with breast cancer between 2004-2006

You may not qualify if:

  • having had irregular screening (less than 3 mammorgrams since 1994)
  • Having breast implants
  • Known carriers of BRCA1/BRCA2 genes
  • Unable to give written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

UH-Monarch

Mayfield Heights, Ohio, 44124, United States

Location

UH-LUICC

Mentor, Ohio, 44060, United States

Location

UH-Southwest

Middleburg Heights, Ohio, 44130, United States

Location

UH-Chagrin Highlands Orange Village Ohio 44122

Orange, Ohio, 44122, United States

Location

UH-Firelands

Sandusky, Ohio, 44870, United States

Location

UH-Green Road

South Euclid, Ohio, 44121, United States

Location

UH-Westlake

Westlake, Ohio, 44145, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Time perspective: Prospective and retrospective. Blood and urine samples will be processed in our lab and stored in a -80 degree freezer until needed. Urine samples will be assessed for levels of bisphenol-A and remaining samples of urine and blood will be stored for future projects.

MeSH Terms

Conditions

Breast NeoplasmsBreast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Cheryl Thompson, PhD

    University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 9, 2007

Study Start

January 10, 2007

Primary Completion

July 21, 2014

Study Completion

July 21, 2014

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

US(8)