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

Ovarian Cancer Clinical Trial

— OVARD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918042
• Other study ID #: D133FR00195
• Status: Recruiting
• Start date: June 21, 2023
• Est. completion date: January 25, 2025

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 25, 2025
• Est. primary completion date: January 25, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Grozniy
Russian Federation	Research Site	Irkutsk
Russian Federation	Research Site	Izhevsk
Russian Federation	Research Site	Kaliningrad
Russian Federation	Research Site	Kaluga
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Lyubertcy
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	N.Novgorod
Russian Federation	Research Site	Nalchik
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	St.Petersburg
Russian Federation	Research Site	Tomsk
Russian Federation	Research Site	Ufa
Russian Federation	Research Site	Vladivostok
Russian Federation	Research Site	Yakutiya
Russian Federation	Research Site	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the demographic and clinical characteristics of the patient population with HRD-positive OC (HRD+ BRCAwt and HRD+ BRCAm)	Demographic and baseline clinical characteristics will be summarized descriptively for the entire cohort of eligible patients.	18 months
Secondary	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	population and the maintenance regimens initiated after the primary OC therapy .	18 months
Secondary	To describe first-line maintenance treatment approaches	population and the maintenance regimens initiated after the primary OC therapy .	18 months