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Prevalence of BRCA in Patients With Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment
BRCA Status Ovarian Cancer Genetic: Testing of BRCA status regarding germline and somatic mutation

Detailed Description:
Explorative analysis will be performed.
Study Design
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Study Type : Observational
Actual Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.
Actual Study Start Date : March 2015
Actual Primary Completion Date : April 1, 2021
Actual Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
patients with primary diagnosis
patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
 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
 Genetic: Testing of BRCA status regarding germline and somatic mutation


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Biospecimen Retention:   Samples With DNA
EDTA Blood sample Tumorblock

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222883


Locations
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Sponsors and Collaborators
AGO Research GmbH
Investigators
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Study Chair: Philipp Harter, PhD MD Kliniken Essen-Mitte, Germany
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AGO Research GmbH
ClinicalTrials.gov Identifier: NCT02222883    
Other Study ID Numbers: AGO-TR 1
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type