Trial Title:
A Non-interventional Prospective Study of 1-st Line Treatment Approaches in OVArian Cancer Patients With HRD+ Status in Russian Federation
NCT ID:
NCT05918042
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Arkhangelsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barnaul
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chelyabinsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Grozniy
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Irkutsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Izhevsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kaliningrad
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kaluga
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Krasnodar
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Krasnoyarsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lyubertcy
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
N.Novgorod
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nalchik
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Novosibirsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Omsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saratov
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sochi
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
St.Petersburg
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tomsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ufa
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Vladivostok
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yakutiya
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yaroslavl
Country:
Russian Federation
Status:
Recruiting
Start date:
June 21, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05918042
