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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ovarian/fallopian tube/primary peritoneal cancer patients | ovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARP inhibitor | Drug | Ovarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1. | Through study completion, an average of 1 year |
| Progression Free Survival (PFS) | PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Ovarian/fallopian tube/primary peritoneal cancer patients treated with PARP inhibitor in the real word.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Ni, MD | Contact | +86 13327833586 | nijingwulin@126.com | |
| Xiaoxiang Chen, MD,PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoxiang Chen, MD,PhD | Jiangsu Cancer Institute & Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaoxiang Chen, MD,PhD | Nanjing | Jiangsu | 210009 | China |
Contact Prof. Chen and Dr. Ni for primary data.
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| C537021 | Kenny-Caffey syndrome, Type 1 |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000067856 | Poly(ADP-ribose) Polymerase Inhibitors |
| C531550 | olaparib |
| C545685 | niraparib |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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The formalin fixation and paraffin embedding (FFPE ) samples from the cytoreductive surgery will be obtained after patients' informed consent.
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |