Clinical trial NCT05574673: Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype
Official title: Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Keywords: Ovarian cancer, observational study, HRD
Lead sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed epithelial ovarian cancer patients (FIGO stage I-II with known BRCA1/2 mutation and FIGO stage III-IV of any histology), who are intended for 1L chemotherapy, will be recruited from specialist care centers across Denmark, Finland, Norway, and Sweden. In total 350 patients will be enrolled applying competitive enrollment. Each patient must meet all the inclusion criteria and none of the exclusion criteria to be included in the study. Under no circumstances can there be exceptions to this rule. Patients who do not meet the entry requirements are screen failures.

Brief summary: This is a prospective observational multi-country, multi-center study of a large real-world cohort of first line (1L) epithelial ovarian cancer patients, exposed to standard of care (SOC) treatment stratified according to BRCA1/2 and HRD status.

Detailed description: The overall objective of the study is to demonstrate the distribution of ovarian cancer by HRD and BRCA1/2 mutational status and further characterize sub-cohorts of long- and short-term responders. Additionally, to collect representative clinical samples for further translational analyses.

The overall objective is separated by two distinct observational periods defined as Observational Period 1 (OP1) and Observational Period 2 (OP2):

* OP1: From date of diagnosis to date of first response assessment following 1L chemotherapy, progression or death, whichever occurs first
* OP2: From date of first response assessment following 1L chemotherapy to maximum 36 months following 1L chemotherapy, death or withdrawal of consent, whichever occurs first.

Objective for Observational Period 1 (OP1) The objective for OP1 is to demonstrate the distribution of ovarian cancer patients with FIGO stage I-II BRCA1/2mut ovarian cancer, or stage III-IV ovarian cancer in cohorts of BRCA1/2, HRD (either BRCA1/2 mutation and/or genomic instability), HRP and HR-unknown patients.

Objective for Observational Period 2 (OP2) The objective for OP2 is to further characterize sub-cohorts of short-term responders (progressing \< 6 months following maintenance treatment) and long-term responders (progressing ≥ 32 months following maintenance treatment) in real-world cohorts of ovarian cancer patients. For FIGO stage I-II BRCA1/2mut or FIGO stage III-IV defined by HRD status determined by Myriad myChoice® CDx HRD test or non-Myriad local HRD test, and BRCA1/2 status.

A total of 350 patients will be enrolled from hospitals in Denmark, Finland, Norway, and Sweden. Competitive enrollment will be applied.

Eligible patients must have newly diagnosed histologically confirmed epithelial ovarian cancer:

* FIGO stage I-II with a known BRCA1/2 mutation (germline/gBRCA or somatic /tBRCA)
* FIGO stage III-IV of any histology of any histology.

Eligibility criteria: Patients are eligible to be included in the study, if all the following inclusion criteria are met:

* Patients with newly diagnosed histologically confirmed epithelial ovarian cancer:

  * FIGO stage I-II with a known BRCA1/2 mutation (germline/gBRCA or somatic/tBRCA)
  * FIGO stage III-IV of any histology
* Women aged ≥18 years of age at the time of diagnosis
* Patients intended for platinum-based chemotherapy treatment
* Patients capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
* Patients consent to provide archival tumor tissue sample

Patients are ineligible to be included in the study, if any of the exclusion criteria are met:

* Non-epithelial ovarian cancer, borderline tumors, or mucinous histology
* Patients with FIGO stage I-II, BRCAwt ovarian cancer

Primary outcomes:
measure: Endpoint OP1
timeFrame: 36 months
Secondary outcomes:
measure: Endpoints OP1 - 1.1
timeFrame: 36 months
measure: Endpoints OP1 - 1.2
timeFrame: 36 months
measure: Endpoints OP1 - 1.3
timeFrame: 36 months
measure: Endpoints OP1 - 1.4
timeFrame: 36 months
measure: Endpoint OP2 - 2.1
timeFrame: 36 months
measure: Endpoint OP2 - 2.2
timeFrame: 36 months
Other outcomes:
Locations:
city: København Ø
country: Denmark
facility: Rigshospitalet
state: Sjaelland
Study officials:
affiliation: NSGO-CTU
name: Mansoor R Mirza, MD
role: STUDY_CHAIR
References: