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Completed

NCT Number: NCT02222883

Prevalence of BRCA in Patients With Ovarian Cancer

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

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Key information

Conditions

BRCA Status Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin, Berlin, Germany

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About this study

Explorative analysis will be performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testing of BRCA status regarding germline and somatic mutation

Genetic

Primary outcomes

  1. 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

  1. Results of Immunohistochemistry in tumor samples

    Time frame: once per sample

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

    Time frame: once per sample

  3. BRCAness tumor phenotype in ovarian cancer (yes/no).

    Time frame: once per sample

  4. Differences of tumor samples from primary and relapsed disease

    Time frame: once per sample for each stage of disease

  5. Patient Survey for perspectives and satisfaction regarding testing and counseling

    Time frame: once after BRCA result is available

    3 questions

  6. Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies

    Time frame: once

Other outcomes

  1. Validate the results from Pennington et al. (Pennington et al. Clin Cancer Res 2014)

    Time frame: once

  2. Evaluate predictive value of PARp-1 expression for HRD mutations

    Time frame: once for all samples

Sponsors and collaborators

Lead sponsor

AGO Research GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2014
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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