OVARD: A Non-interventional Prospective Study of 1-st Line Treatment Approaches in OVArian Cancer Patients With HRD+ Status in Russian Federation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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 .
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Arkhangelsk | Russian Federation | ||
| 2 | Research Site | Chelyabinsk | Russian Federation | ||
| 3 | Research Site | Grozny | Russian Federation | ||
| 4 | Research Site | Irkutsk | Russian Federation | ||
| 5 | Research Site | Kaliningrad | Russian Federation | ||
| 6 | Research Site | Kaluga | Russian Federation | ||
| 7 | Research Site | Krasnodar | Russian Federation | ||
| 8 | Research Site | Krasnoyarsk | Russian Federation | ||
| 9 | Research Site | Moscow | Russian Federation | ||
| 10 | Research Site | Nalchik | Russian Federation | ||
| 11 | Research Site | Nizhniy Novgorod | Russian Federation | ||
| 12 | Research Site | Saint-Petersburg | Russian Federation | ||
| 13 | Research Site | Saratov | Russian Federation | ||
| 14 | Research Site | Tomsk | Russian Federation | ||
| 15 | Research Site | Tyumen | Russian Federation | ||
| 16 | Research Site | Ufa | Russian Federation | ||
| 17 | Research Site | Vladivostok | Russian Federation | ||
| 18 | Research Site | Voronezh | Russian Federation | ||
| 19 | Research Site | Yaroslavl | Russian Federation |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D133FR00195