NCT05574673

Brief Summary

This is a prospective observational multi-country, multi-center study of a large real-world cohort of first line (1L) epithelial ovarian cancer patients, exposed to standard of care (SOC) treatment stratified according to BRCA1/2 and HRD status.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
75mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress36%
Dec 2022Jul 2032

First Submitted

Initial submission to the registry

October 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2032

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5.4 years

First QC Date

October 5, 2022

Last Update Submit

February 24, 2026

Conditions

Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancer

Keywords

Ovarian cancer, observational study, HRD

Outcome Measures

Primary Outcomes (1)

  • Endpoint OP1

    Frequency of surgical resection

    60 months

Secondary Outcomes (6)

  • Endpoints OP1 - 1.1

    60 months

  • Endpoints OP1 - 1.2

    60 months

  • Endpoints OP1 - 1.3

    60 months

  • Endpoints OP1 - 1.4

    60 months

  • Endpoint OP2 - 2.1

    60 months

  • +1 more secondary outcomes

Study Arms (1)

Ovarian cancer patients

Newly diagnosed patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer

Other: Standard of care

Interventions

Standard of careOTHER

Patients receive standard of care treatment according to local and national guidelines

Ovarian cancer patients

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed epithelial ovarian cancer patients (FIGO stage I-II with known BRCA1/2 mutation and FIGO stage III-IV of any histology), who are intended for 1L chemotherapy, will be recruited from specialist care centers across Denmark, Finland, Norway, and Sweden. In total 1000 patients will be enrolled applying competitive enrollment. Each patient must meet all the inclusion criteria and none of the exclusion criteria to be included in the study. Under no circumstances can there be exceptions to this rule. Patients who do not meet the entry requirements are screen failures.

You may qualify if:

  • Patients with newly diagnosed histologically confirmed epithelial ovarian cancer:
  • FIGO stage I-II with a known BRCA1/2 mutation (germline/gBRCA or somatic/tBRCA)
  • FIGO stage III-IV of any histology
  • Women aged ≥18 years of age at the time of diagnosis
  • Patients intended for platinum-based chemotherapy treatment
  • Patients capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
  • Patients consent to provide archival tumor tissue sample

You may not qualify if:

  • Non-epithelial ovarian cancer, borderline tumors, or mucinous histology
  • Patients with FIGO stage I-II, BRCAwt ovarian cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

København Ø, Region Sjælland, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsKenny-Caffey syndrome, Type 1

Interventions

Standard of Care

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 DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Mansoor R Mirza, MD

    NSGO-CTU

    STUDY CHAIR

Central Study Contacts

Kristine Madsen, MD

CONTACT

004535453311kristine.madsen.01@regionh.dk

Henriette W Hansen, MSc

CONTACT

004535453311henriette.watson.hansen@regionh.dk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 10, 2022

Study Start

December 1, 2022

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

July 1, 2032

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

DK(1)