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A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00989638
Recruitment Status : Active, not recruiting
First Posted : October 5, 2009
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date October 1, 2009
First Posted Date October 5, 2009
Last Update Posted Date May 20, 2020
Study Start Date June 2004
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2018)
  • Creation of registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women [ Time Frame: Until enrollment is complete ]
  • Impact of intensive breast cancer screening on patient reported outcomes [ Time Frame: 5 years ]
Original Primary Outcome Measures
 (submitted: October 2, 2009)
We hope to prove that combining multiple screening measures including biomarkers improves the chances that, if you have a small cancer or pre-cancer, it will be found early. [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer
Official Title A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer
Brief Summary The purpose of this study is to develop a coordinated, standardized screening program for the early detection of breast cancer in high-risk women. This would include Breast Mammography and Magnetic Resonance Imaging (MRI) examination of your breasts. The University of Chicago Department of Radiology is performing research to develop better ways of imaging the breast. The investigators would like to be able to reliably identify abnormal tissue and determine whether abnormal areas contain cancer without surgical procedures (i.e., a biopsy which involves removing breast tissue with a needle or surgical instrument). Annual mammography has already been recommended for the patient based on family history or personal history of cancer. In young women, dense breasts sometimes make it difficult to find abnormal changes on breast cancer screening (mammograms). MRI, in combination with mammography, may increase the rate of detection of early cancers. In addition, MRI can provide better images of breast tissue. The investigators hope to prove that combining multiple screening measures including biomarkers improves the chances that, if you have a small cancer or pre-cancer, it will be found early. This study will also evaluate quality of life measures during breast cancer screening and compare breast MRI and mammogram in a high-risk population. The investigators will establish a database of clinical characteristics, blood biomarkers and interventions that will be saved for future analysis and aid in the development of more effective screening in high-risk women. This research will also help us develop tools for studies in the future.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women at high risk for breast cancer.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Women at high risk for breast cancer
Publications * Guindalini RSC, Zheng Y, Abe H, Whitaker K, Yoshimatsu TF, Walsh T, Schacht D, Kulkarni K, Sheth D, Verp MS, Bradbury AR, Churpek J, Obeid E, Mueller J, Khramtsova G, Liu F, Raoul A, Cao H, Romero IL, Hong S, Livingston R, Jaskowiak N, Wang X, Debiasi M, Pritchard CC, King MC, Karczmar G, Newstead GM, Huo D, Olopade OI. Intensive Surveillance with Biannual Dynamic Contrast-Enhanced Magnetic Resonance Imaging Downstages Breast Cancer in BRCA1 Mutation Carriers. Clin Cancer Res. 2019 Mar 15;25(6):1786-1794. doi: 10.1158/1078-0432.CCR-18-0200. Epub 2018 Aug 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 30, 2018)
305
Original Estimated Enrollment
 (submitted: October 2, 2009)
500
Estimated Study Completion Date February 2027
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Each woman will meet one or more of the criteria below:

  • Known BRCA1 or BRCA2 carrier (must be older than 21 years)
  • Any mutation carrier in hereditary breast cancer susceptibility genes that is known to increase the risk for breast cancer (regardless of age). Some examples of these would include TP53, PTEN, BRCA1 and BRCA2, CHEK2, ATM, and CDH1 and other identified genetic markers conferring greater than 2.5 fold increased breast cancer risk in a polygenic model.
  • For women who chose not to have genetic testing or test negative, probability of being a BRCA1 or BRCA2 carrier of 20% or greater based on BRCAPRO analysis or ≥ 25% risk of being a mutation carrier by any Genetic model such as Couch, Myriad, BODICEA, in addition to a lifetime breast cancer risk >=20% by CARE, Tyler Cuzick, or Claus model
  • Personal history of breast cancer before age 35 years and no evidence of disease recurrence for at least two years.
  • Any woman of African ancestry whose 1st degree relative (mother or sister) or 2nd degree relative (aunt, grandmother) if paternal lineage suspected diagnosed with breast cancer under age 40, regardless of risk model calculation
  • Have a personal history of ductal carcinoma in situ (DCIS) diagnosed at or before age 35 AND a first degree relative who had been diagnosed with breast cancer before age 50 OR has a first degree relative diagnosed with ovarian cancer at any age
  • Any female cancer survivor who received chest irradiation before age 30 for any disease including Hodgkin's, a sarcoma, neuroblastoma, or other medical condition.

In addition to meeting one of the above criteria, women must meet all of the following:

  • willing to travel to University of Chicago Medical Center for imaging studies as well as any necessary follow-up procedures.
  • have at least one breast that has not been irradiated for cancer
  • be at least 25 years of age or at least 5 years younger than the first case of breast cancer diagnosis in the family. (This applies only to high risk women who are not BRCA1 or BRCA2 mutation carriers)
  • be able to give informed consent

Exclusion Criteria:

Women will be excluded if they meet one of the following:

  • active cancer at the time of enrollment. A prior history of breast cancer is permitted if the subject has completed chemotherapy and is considered disease-free at the time of enrollment.
  • current pregnancy or plans for pregnancy within two years of enrollment
  • presence of a pacemaker or any other metallic foreign objects in their body that interferes with an MRI
  • breast surgery within two weeks of study entry
  • previous bilateral mastectomy (prophylactic or therapeutic)
  • history of kidney disease or abnormal kidney tests
  • Women who test negative in a family with identifiable BRCA mutations are ineligible regardless of risk calculation
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00989638
Other Study ID Numbers 13073B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Chicago
Study Sponsor University of Chicago
Collaborators Not Provided
Investigators
Principal Investigator: Olufunmilayo Olopade, MD University of Chicago
PRS Account University of Chicago
Verification Date May 2020