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Clinical Trials/NCT02222883
NCT02222883
Completed
Not Applicable

Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.

AGO Research GmbH19 sites in 1 country530 target enrollmentMarch 2015
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ConditionsBRCA StatusOvarian Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
BRCA Status
Sponsor
AGO Research GmbH
Enrollment
530
Locations
19
Primary Endpoint
Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of this prospective registration and translational research study is to evaluate the praevalence of BRCA regarding germline and somatic mutations.

Detailed Description

Explorative analysis will be performed.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
April 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)

Time Frame: once per sample

Secondary Outcomes

  • Results of Immunohistochemistry in tumor samples(once per sample)
  • Patient Survey for perspectives and satisfaction regarding testing and counseling(once after BRCA result is available)
  • Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies(once)
  • Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)(once per sample)
  • BRCAness tumor phenotype in ovarian cancer (yes/no).(once per sample)
  • Differences of tumor samples from primary and relapsed disease(once per sample for each stage of disease)

Study Sites (19)

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