An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy

Ovarian Cancer Clinical Trial

Official title:

An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255861
• Other study ID #: FUOBGY2021-246
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2022
• Source: Obstetrics & Gynecology Hospital of Fudan University
• Contact: Xin Wu, PHD
• Phone: (021)33189900-6529
• Email: wuxin_fc[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project intends to evaluate the sensitivity of different Homologous Recombination Deficiency (HRD) score to Poly(ADP-ribose) polymerase inhibitor (PARPi) by retrospectively analyzing the tissue samples of patients with ovarian cancer using PARPi, and to determine the cut off value of the HRD score algorithm suitable for the Chinese population, so as to provide evidence for the role of PARPi in ovarian cancer. The screening of the beneficiaries of maintenance therapy provides precise guidance and can be used as a reference for other cancer types.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. age = 18 years;

2. high-grade serous/endometrioid epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;

3. FIGO stage III or IV;

4. at least 6 cycles and no more than 9 cycles First-line platinum-containing chemotherapy;

5. CR or PR after chemotherapy;

6. ECOG 0-1;

7. sufficient biological samples for HRD score detection;

8. patients signed informed consent;

9. good bone marrow function.

Exclusion Criteria:

1. incomplete follow-up records of survival information;

2. unqualified biological sample quality control

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
China	The Obstetrics and Gynecology Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xin Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homologous Recombination Deficiency score	Optimize the Homologous Recombination Deficiency scoring algorithm to calculate the Homologous Recombination Deficiency score of each patient's ovarian cancer tissue	After the ovarian tissue is obtained, an average of 3 year