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Prevalence of BRCA in Patients With Ovarian Cancer (BRCA-Screening)

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 : Active, not recruiting
First Posted : August 21, 2014
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
AGO Research GmbH

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.

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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.
Study Start Date : March 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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



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 ]
  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 ]
  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 ]


Information from the National Library of Medicine

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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.

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
Show Show 20 study locations
Sponsors and Collaborators
AGO Research GmbH
Investigators
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Study Chair: Philipp Harter, PhD MD Kliniken Essen-Mitte, Germany
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: January 10, 2020
Last Verified: January 2020
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 Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type