A Non-interventional Prospective Study of 1-st Line Treatment Approaches in OVArian Cancer Patients With HRD+ Status in Russian Federation

Active, not recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT05918042
• Lead Sponsor: AstraZeneca

Brief Summary

Study population will consist of HRD+ (BRCAm +/- positive genomic instability score according to used test system) OC with available medical history. It is estimated that approximately 400 patients will be enrolled in approximately 25 sites. Demographic and clinical characteristics, treatment approaches and outcomes in HRD+ patients with high-grade epithelial ovarian, primary peritoneal, and/or fallopian tube cancer will be collected at baseline and on prospective visits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Study Start: 2023-06-21
• Study First Posted: 2023-06-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Patients ≥18 years of age;
• Willing and ability to provide written informed consent for participation in the study;
• Known status HRD+ (positive BRCAm test and/or positive Genomic Instability test);
• Patients with histologically confirmed diagnosis of high-grade IC-IV FIGO stages epithelial ovarian, primary peritoneal, and/or fallopian tube cancer;
• Completed primary treatment (surgery and/or 1st line CT +/- bevacizumab) no more than 3 months after completion of primary treatment.

Exclusion Criteria

• Patients participating in other clinical studies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the demographic and clinical characteristics of the patient population with HRD-positive OC (HRD+ BRCAwt and HRD+ BRCAm)	18 months	Demographic and baseline clinical characteristics will be summarized descriptively for the entire cohort of eligible patients.

Secondary Outcome Measures

Name	Time	Method
To describe diagnostic and primary treatment approaches (surgery, first line chemotherapy+/-bevacizumab) of HRD+ with high-grade, epithelial ovarian, primary peritoneal, and/or fallopian tube cancer in routine practice	18 months	population and the maintenance regimens initiated after the primary OC therapy .
To describe first-line maintenance treatment approaches	18 months	population and the maintenance regimens initiated after the primary OC therapy .

Trial Locations

Locations (1)

Research Site; 🇷🇺 Yaroslavl, Russian Federation