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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00989638 |
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Date of registration:
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01/10/2009 |
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Primary sponsor: |
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Public title:
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A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer
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Scientific title:
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A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00989638 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Olufunmilayo Olopade, MD |
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Address:
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Telephone:
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773-702-1632 |
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Email:
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folopade@medicine.bsd.uchicago.edu |
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Affiliation:
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Name:
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Olufunmilayo Olopade, MD |
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Address:
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Telephone:
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773-702-1632 |
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Email:
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folopade@medicine.bsd.uchicago.edu |
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Affiliation:
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Name:
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Olufunmilayo Olopade, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Chicago |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Known BRCA1 or BRCA2 carrier (regardless of age)
- 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.
- 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 Couch model in addition to a lifetime breast
cancer risk >=20% by Gail, CARE, or Claus model
- Personal history of breast cancer before age 35 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 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.
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
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Primary Outcome(s)
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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]
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Secondary ID(s)
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UCIRB# 13073B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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