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

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ClinicalTrials.gov Identifier: NCT05918042
Recruitment Status : Recruiting
First Posted : June 26, 2023
Last Update Posted : May 21, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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
Ovarian Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentre, Non-interventional, Observational, Prospective Study to Evaluate 1-st Line Treatment Approaches in HRD+ Ovarian Cancer Patients in Russian Federation
Actual Study Start Date : June 21, 2023
Estimated Primary Completion Date : January 25, 2025
Estimated Study Completion Date : January 25, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To describe the demographic and clinical characteristics of the patient population with HRD-positive OC (HRD+ BRCAwt and HRD+ BRCAm) [ Time Frame: 18 months ]
    Demographic and baseline clinical characteristics will be summarized descriptively for the entire cohort of eligible patients.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 18 months ]
    population and the maintenance regimens initiated after the primary OC therapy .

  2. To describe first-line maintenance treatment approaches [ Time Frame: 18 months ]
    population and the maintenance regimens initiated after the primary OC therapy .


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05918042


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Russian Federation
Research Site Recruiting
Arkhangelsk, Russian Federation
Research Site Recruiting
Barnaul, Russian Federation
Research Site Recruiting
Chelyabinsk, Russian Federation
Research Site Recruiting
Grozniy, Russian Federation
Research Site Recruiting
Irkutsk, Russian Federation
Research Site Not yet recruiting
Izhevsk, Russian Federation
Research Site Recruiting
Kaliningrad, Russian Federation
Research Site Recruiting
Kaluga, Russian Federation
Research Site Recruiting
Krasnodar, Russian Federation
Research Site Recruiting
Krasnoyarsk, Russian Federation
Research Site Not yet recruiting
Lyubertcy, Russian Federation
Research Site Recruiting
Moscow, Russian Federation
Research Site Recruiting
N.Novgorod, Russian Federation
Research Site Not yet recruiting
Nalchik, Russian Federation
Research Site Recruiting
Novosibirsk, Russian Federation
Research Site Not yet recruiting
Saratov, Russian Federation
Research Site Recruiting
St.Petersburg, Russian Federation
Research Site Recruiting
Tomsk, Russian Federation
Research Site Recruiting
Ufa, Russian Federation
Research Site Recruiting
Vladivostok, Russian Federation
Research Site Recruiting
Yakutiya, Russian Federation
Research Site Recruiting
Yaroslavl, Russian Federation
Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05918042    
Other Study ID Numbers: D133FR00195
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: May 21, 2024
Last Verified: May 2024
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type