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Prevalence of BRCA in Patients With Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT02222883
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
AGO Research GmbH

Tracking Information
First Submitted Date August 19, 2014
First Posted Date August 21, 2014
Last Update Posted Date June 16, 2021
Actual Study Start Date March 2015
Actual Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2014)
Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which) [ Time Frame: once per sample ]
Original Primary Outcome Measures
 (submitted: August 19, 2014)
Evidence of germline alterations in BRCA1/2 and other ovarian cancer predisposing genes [ Time Frame: once per sample ]
Change History
Current Secondary Outcome Measures
 (submitted: June 11, 2021)
  • Results of Immunohistochemistry in tumor samples [ Time Frame: once per sample ]
  • Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which) [ Time Frame: once per sample ]
  • BRCAness tumor phenotype in ovarian cancer (yes/no). [ Time Frame: once per sample ]
  • Differences of tumor samples from primary and relapsed disease [ Time Frame: once per sample for each stage of disease ]
  • Patient Survey for perspectives and satisfaction regarding testing and counseling [ Time Frame: once after BRCA result is available ]
    3 questions
  • Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies [ Time Frame: once ]
Original Secondary Outcome Measures
 (submitted: August 19, 2014)
  • Immunohistochemistry and DNA extraction from tumor samples [ Time Frame: once per sample ]
  • Evidence of somatic alterations in BRCA1/2 and other ovarian cancer predisposing genes [ Time Frame: once per sample ]
  • Evidence for a BRCAness tumor phenotype in ovarian cancer. [ Time Frame: once per sample ]
  • Differences of tumor samples from primary and relapsed disease [ Time Frame: once per sample for each stage of disease ]
  • Evaluation of patient perspectives and satisfaction regarding testing and counseling (survey) [ Time Frame: once after BRCA result is available ]
Current Other Pre-specified Outcome Measures
 (submitted: June 11, 2021)
  • Validate the results from Pennington et al. (Pennington et al. Clin Cancer Res 2014) [ Time Frame: once ]
  • Evaluate predictive value of PARp-1 expression for HRD mutations [ Time Frame: once for all samples ]
Original Other Pre-specified Outcome Measures
 (submitted: August 19, 2014)
  • Validate the results from Pennington et al. (Pennington et al. Clin Cancer Res 2014) [ Time Frame: once ]
  • Evaluate predictive value of PARp-1 expression for HRD mutations [ Time Frame: once for all samples ]
  • Identify BRCA1/2 promoter hypermethylation/epigenetic alterations in addition to genetic alterations. [ Time Frame: once for all samples ]
  • Identify and characterize large rearrangements in BRCA1/2 with MLPA in the tumor tissue probes [ Time Frame: once for all samples ]
 
Descriptive Information
Brief Title Prevalence of BRCA in Patients With Ovarian Cancer
Official Title Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
EDTA Blood sample Tumorblock
Sampling Method Probability Sample
Study Population 500 consecutive patients (up to 250 patients with primary diagnosis and up to 250 patients with platinum-sensitive recurrence of ovarian cancer.
Condition
  • BRCA Status
  • Ovarian Cancer
Intervention Genetic: Testing of BRCA status regarding germline and somatic mutation
Study Groups/Cohorts
  • patients with primary diagnosis
    patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
    Intervention: Genetic: Testing of BRCA status regarding germline and somatic mutation
  • patients with platinum-sensitive recurrence
    patients with platinum-sensitive recurrence of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
    Intervention: Genetic: Testing of BRCA status regarding germline and somatic mutation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 25, 2015)
530
Original Estimated Enrollment
 (submitted: August 19, 2014)
500
Actual Study Completion Date April 1, 2021
Actual Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
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.
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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02222883
Other Study ID Numbers AGO-TR 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party AGO Research GmbH
Original Responsible Party Same as current
Current Study Sponsor AGO Research GmbH
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: Philipp Harter, PhD MD Kliniken Essen-Mitte, Germany
PRS Account AGO Research GmbH
Verification Date June 2021