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

NCT ID: NCT05255861

Last Updated: 2022-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Xin Wu

OTHER

Sponsor Role lead

Responsible Party

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Xin Wu

Department Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xin Wu, PHD

Role: PRINCIPAL_INVESTIGATOR

The Obstetrics and Gynecology Hospital of Fudan University

Locations

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The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Wu, PHD

Role: CONTACT

(021)33189900-6529

Ling Qiu, MD

Role: CONTACT

(021)33189900-6529

Facility Contacts

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Xin Wu, PHD

Role: primary

(021)33189900-6529

Other Identifiers

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FUOBGY2021-246

Identifier Type: -

Identifier Source: org_study_id

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