NCT05206890

Brief Summary

Ovarian cancer is one of the most fatal malignant tumors that threaten women's health. The incidence rate is the third place among the female reproductive system malignant tumors, and the mortality rate ranks the first in gynecologic malignancies, the majority of patients have advanced diseases at the time of diagnosis. This observational study is to evaluate the safety and efficacy of fluzoparib in ovarian cancer patients under real conditions, especially in various subgroups of ovarian cancer patients, in order to provide information about treatment modes for ovarian cancer patients in real-world diagnosis and treatment, and preliminarily evaluate the pharmacoeconomic of fluzoparib in the treatment of ovarian cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
490

participants targeted

Target at P75+ for all trials

Timeline
80mo left

Started Jan 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 Progress39%
Jan 2022Dec 2032

First Submitted

Initial submission to the registry

January 11, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

5 years

First QC Date

January 11, 2022

Last Update Submit

January 25, 2022

Conditions

Ovarian Cancer

Keywords

real world study

Outcome Measures

Primary Outcomes (1)

  • incidence of ≥ grade 3 Hematology related adverse event according to NCI CTCAE v5.0

    the safety of fluzoparib in ovarian cancer under real-world conditions, especially Incidence of Hematology related adverse reactions ≥ grade 3

    30 days after the last dose of fluzoparib

Secondary Outcomes (7)

  • incidence of other adverse event according to NCI CTCAE v5.0

    30 days after the last dose of fluzoparib

  • overall survival (OS)

    6 years

  • Progression free survival (PFS)

    6 years

  • Objective Response Rate (ORR)

    6 years

  • Disease Control Rate (DCR)

    6 years

  • +2 more secondary outcomes

Study Arms (1)

fluzoparib treatment

patients with Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy

Drug: fluzoparib monotherapy or combination therapy

Interventions

fluzoparib monotherapy or combination therapyDRUG

patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy

fluzoparib treatment

Eligibility Criteria

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

Patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer had decided to use Fluzoparibb at the time of enrollment in this study

You may qualify if:

  • Sign informed consent and voluntarily join the study;
  • Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed by histology or cytology;
  • ≥ 18 years old;
  • The investigator determined that the patient could receive fluzoparib monotherapy or combination therapy;
  • For patients with fertility, effective contraceptive methods should be used during the study period and within 90 days after the last administration of fluzoparib

You may not qualify if:

  • There is evidence that the patient is a pregnant or lactating woman;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

HRD score and BRCA gene test should be conducted using blood and tumor samples. serum CA125 levels should also be tested.

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Combined Modality Therapy

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 25, 2022

Study Start

January 14, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2032

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

CN(1)