Homologous Recombination Deficiency in Chinese Ovarian Cancer Patients

NCT ID: NCT05044091

Last Updated: 2021-09-14

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-09-30

Brief Summary

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Homologous recombination deficiency (HRD) is an important molecular biomarker for Poly (ADP-ribose) polymerase inhibitors (PARPi) which is a significant progress in the treatment of ovarian cancer. However, the proportion of HRD positive in real world and relationship of HRD status with PARPi in Chinese ovarian cancer patients remains unknown.

Detailed Description

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This study intends to perform HRD testing of ovarian cancer in real world from China and correlate HRD status and clinical characteristics with therapeutic outcomes.

Conditions

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Ovarian Cancer HRD PARP Inhibitor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ovarian/fallopian tube/primary peritoneal cancer patients

ovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks

PARP inhibitor

Intervention Type DRUG

Ovarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions

Interventions

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PARP inhibitor

Ovarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions

Intervention Type DRUG

Other Intervention Names

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Lynparza, Zejula

Eligibility Criteria

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Inclusion Criteria

1. Subjects join the study voluntarily and sign informed consent;
2. Female subjects are older than 18 years;
3. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
4. Life expectancy≥3 months;
5. Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous or endometrioid histology;
6. Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.

Exclusion Criteria

1. Personnel involved in the formulation or implementation of the research plan;
2. Patient participated in other clinical trails using other experimental drugs at the same time as the study;
3. The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;
4. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
5. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Xiaoxiang Chen

OTHER

Sponsor Role lead

Responsible Party

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Xiaoxiang Chen

Academic secretary of gynecological oncology Committee of Jiangsu anti cancer association

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaoxiang Chen, MD,PhD

Role: STUDY_CHAIR

Jiangsu Cancer Institute & Hospital

Locations

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Xiaoxiang Chen, MD,PhD

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Jing Ni, MD

Role: CONTACT

+86 13327833586

Xiaoxiang Chen, MD,PhD

Role: CONTACT

Facility Contacts

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Jing Ni, MD

Role: primary

+86 13327833586

Other Identifiers

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JiangsuCIH010

Identifier Type: -

Identifier Source: org_study_id

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