Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype

Ovarian Cancer Clinical Trial

— HERO  

Official title:

Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574673
• Other study ID #: NSGO-CTU-HERO
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 1, 2028

Study information

• Verified date: March 2023
• Source: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
• Contact: Mansoor R Mirza, MD
• Phone: 004535459624
• Email: mansoor.raza.mirza[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 1, 2028
• Est. primary completion date: December 1, 2028
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Cancer

Intervention

Other:
• Standard of care
Patients receive standard of care treatment according to local and national guidelines

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København Ø	Sjaelland

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endpoint OP1	Frequency of surgical resection	36 months
Secondary	Endpoints OP1 - 1.1	- First line anti-cancer treatment including outcome	36 months
Secondary	Endpoints OP1 - 1.2	- +/- Residual disease following Primary Cytoreductive Surgery (P-CRS)	36 months
Secondary	Endpoints OP1 - 1.3	- Overall Response Rate (ORR)	36 months
Secondary	Endpoints OP1 - 1.4	- BRCA1/2 and HRD status	36 months
Secondary	Endpoint OP2 - 2.1	- Number of patients receiving maintenance treatment or not	36 months
Secondary	Endpoint OP2 - 2.2	- Progression-Free-Survival (PFS) at 6, 12, 24 and 32 months	36 months