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Main
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Note: This record shows only 22 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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21 June 2021 |
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Main ID: |
NCT02222883 |
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Date of registration:
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19/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prevalence of BRCA in Patients With Ovarian Cancer
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Scientific title:
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Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer. |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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530 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02222883 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Philipp Harter, PhD 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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Kliniken Essen-Mitte, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female ovarian cancer patients aged >= 18 years.
- Women with first diagnosis of epithelial ovarian cancer OR women diagnosed with
platinum-sensitive recurrent ovarian cancer.
- Multiple platinum based prior therapies are allowed.
Exclusion Criteria:
- Non-epithelial ovarian malignancy.
- Platinum-resistant or refractory disease.
- Paraffin embedded tumor samples not available.
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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BRCA Status
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Ovarian Cancer
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Intervention(s)
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Genetic: Testing of BRCA status regarding germline and somatic mutation
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Primary Outcome(s)
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Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
[Time Frame: once per sample]
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Secondary Outcome(s)
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Results of Immunohistochemistry in tumor samples
[Time Frame: once per sample]
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Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
[Time Frame: once per sample]
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Differences of tumor samples from primary and relapsed disease
[Time Frame: once per sample for each stage of disease]
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Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies
[Time Frame: once]
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BRCAness tumor phenotype in ovarian cancer (yes/no).
[Time Frame: once per sample]
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Patient Survey for perspectives and satisfaction regarding testing and counseling
[Time Frame: once after BRCA result is available]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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