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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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25 March 2013 |
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Main ID: |
NCT00032201 |
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Date of registration:
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09/03/2002 |
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Primary sponsor: |
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Public title:
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Cell Lines From High-Risk Breast Tissue
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Scientific title:
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Establishment of Normal High Risk Breast Epithelial Cell Cultures, and A High Risk Cell Line and Tissue Repository From Breast Tissue From Women at High Risk of Breast Cancer |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00032201 |
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Study type:
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Observational |
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Study design:
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N/A
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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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David N Danforth, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Cancer Institute (NCI) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
To be eligible, women must have one of the following:
Women 20-80 years of age who have an increased risk of breast cancer because they are
members of a high risk breast or ovarian cancer family. An Individual with a family
history of verified breast and/or ovarian cancer is defined as including one of the
following: 1) at least four cases of breast cancer. 2) Three cases of breast cancer and at
least one case of ovarian cancer (two cases of ovarian cancer of which have to be first
degree relatives). 3) Two cases of ovarian cancer in first degree relatives. High risk
families may also include those with at least 4 cases of early onset (age less than 60)
breast cancer or ovarian cancer (diagnosis at any age), or any family known to segregate a
mutation in BRCA1 or another predisposing gene (i.e. BRCA2).
Women with a history of ipsilateral breast cancer, either invasive or in situ, and a
normal contralateral breast by mammography (within the past 12 months) and a normal
physical examination of the contralateral breast and adjacent lymph node bearing areas, or
be undergoing prophylactic mastectomy.
Women without breast cancer but with a Gail model estimate of 5-year risk of breast cancer
of 1.67 percent or higher.
Women with bilateral breast cancer (invasive or in situ) who have not received whole
breast irradiation to both breasts.
Women with a previous history of mediastinal irradiation for lymphoma before the age of 30
and who are now greater than or equal to 5 years since completing radiation therapy.
Normal women not at increased risk of breast cancer (Gail model Index of less than 1.50%)
and without abnormal findings in the breast by physical examination and mammography to
serve as normal control tissue.
Women with a mutation in a breast cancer susceptibility gene, but whose family history is
not known.
Absence of significant cardiac, hepatic or renal disease, which, in the opinion of the PI,
is likely to cause metabolic changes in the breast tissues.
EXCLUSION CRITERIA:
Chemotherapy within 3 weeks prior to breast biopsy procedure.
Pregnancy,
White blood count less than 2000, platelet count less than 50,000.
Concurrent infection.
A history of bilateral whole breast radiation therapy.
A suspicious unbiopsied lesion by physical examination or mammography of the breast(s)
which is being studied.
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Healthy
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Secondary ID(s)
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02-C-0144
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020144
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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