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

Multicentre, Non-interventional, Observational, Prospective Study to Evaluate 1-st Line Treatment Approaches in HRD+ Ovarian Cancer Patients in Russian Federation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05918042

Acronym

OVARD

Enrollment

414

Registered

2023-06-26

Start date

2023-06-21

Completion date

2025-05-29

Last updated

2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 .

Countries

Russia

Outcome results