NCT05918042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
414

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

June 21, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2025

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

June 15, 2023

Last Update Submit

May 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • To describe first-line maintenance treatment approaches

    18 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients participating in other clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Research Site

Arkhangelsk, Russia

Location

Research Site

Barnaul, Russia

Location

Research Site

Chelyabinsk, Russia

Location

Research Site

Grozny, Russia

Location

Research Site

Irkutsk, Russia

Location

Research Site

Izhevsk, Russia

Location

Research Site

Kaliningrad, Russia

Location

Research Site

Kaluga, Russia

Location

Research Site

Krasnodar, Russia

Location

Research Site

Krasnoyarsk, Russia

Location

Research Site

Lyubertcy, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

N.Novgorod, Russia

Location

Research Site

Nal'chik, Russia

Location

Research Site

Novosibirsk, Russia

Location

Research Site

Omsk, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Saratov, Russia

Location

Research Site

Sochi, Russia

Location

Research Site

Tomsk, Russia

Location

Research Site

Ufa, Russia

Location

Research Site

Vladivostok, Russia

Location

Research Site

Yakutiya, Russia

Location

Research Site

Yaroslavl, Russia

Location

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2023

First Posted

June 26, 2023

Study Start

June 21, 2023

Primary Completion

May 29, 2025

Study Completion

May 29, 2025

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations