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History of Changes for Study: NCT02222883
BRCA-Screening in Ovarian Cancer (BRCA-Screening)
Latest version (submitted June 11, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 19, 2014 None (earliest Version on record)
2 August 21, 2014 Outcome Measures and Study Status
3 April 24, 2015 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Study Identification
4 August 25, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 February 16, 2016 Study Description, IPDSharing, Study Status and Study Identification
6 February 22, 2017 Study Status and Oversight
7 May 7, 2018 Study Status
8 January 8, 2020 Study Status
9 June 11, 2021 Recruitment Status, Study Status, Outcome Measures, Study Design and Study Identification
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Study NCT02222883
Submitted Date:  August 19, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: AGO-TR 1
Brief Title: BRCA-Screening in Ovarian Cancer (BRCA-Screening)
Official Title: Incidence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2014
Overall Status: Not yet recruiting
Study Start: September 2014
Primary Completion: March 2020 [Anticipated]
Study Completion:
First Submitted: August 19, 2014
First Submitted that
Met QC Criteria:
August 19, 2014
First Posted: August 21, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 19, 2014
Last Update Posted: August 21, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: AGO Research GmbH
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The aim of this prospective registration and translational research study is to evaluate the incidence of BRCA regarding germline and somatic mutations.
Detailed Description:
Open or close this module Conditions
Conditions: BRCA Status
Ovarian Cancer
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 500 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Evidence of germline alterations in BRCA1/2 and other ovarian cancer predisposing genes
[ Time Frame: once per sample ]

Secondary Outcome Measures:
1. Immunohistochemistry and DNA extraction from tumor samples
[ Time Frame: once per sample ]

2. Evidence of somatic alterations in BRCA1/2 and other ovarian cancer predisposing genes
[ Time Frame: once per sample ]

3. Evidence for a BRCAness tumor phenotype in ovarian cancer.
[ 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. Evaluation of patient perspectives and satisfaction regarding testing and counseling (survey)
[ Time Frame: once after BRCA result is available ]

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 ]

3. Identify BRCA1/2 promoter hypermethylation/epigenetic alterations in addition to genetic alterations.
[ Time Frame: once for all samples ]

4. Identify and characterize large rearrangements in BRCA1/2 with MLPA in the tumor tissue probes
[ Time Frame: once for all samples ]

Open or close this module Eligibility
Study Population: 500 consecutive patients (up to 250 patients with primary diagnosis and up to 250 patients with platinum-sensitive recurrence of ovarian cancer.
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Irene Syré
Telephone: +49 201 959812 Ext. 0
Email: office-essen@ago-ovar.de
Study Officials: Philipp Harter, PhD MD
Study Chair
Kliniken Essen-Mitte, Germany
Locations: Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinik Carl Gustav Carus
Dresden, Germany
Evangelisches Krankenhaus
Düsseldorf, Germany
Kliniken Essen-Mitte
Essen, Germany
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hannover, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Zentrum für Gynäkologische Onkologie
Kiel, Germany
Klinikum rechts der Isar
München, Germany
LMU München, Klinik Großhadern
München, Germany
Universitäts-Frauenklinik
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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