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

NCT ID: NCT05918042

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-21

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Arkhangelsk, , Russia

Site Status

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Barnaul, , Russia

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Chelyabinsk, , Russia

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Grozny, , Russia

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Irkutsk, , Russia

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Izhevsk, , Russia

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Kaliningrad, , Russia

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Kaluga, , Russia

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Krasnodar, , Russia

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Krasnoyarsk, , Russia

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Lyubertcy, , Russia

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Moscow, , Russia

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N.Novgorod, , Russia

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Nal'chik, , Russia

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Novosibirsk, , Russia

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Omsk, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Sochi, , Russia

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Tomsk, , Russia

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Ufa, , Russia

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Vladivostok, , Russia

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Yakutiya, , Russia

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Yaroslavl, , Russia

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Countries

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Russia

Other Identifiers

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D133FR00195

Identifier Type: -

Identifier Source: org_study_id

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