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Epithelial ovarian cancer (EOC) is the most lethal gynecological malignancy. PARP inhibitors(PARPi) are an important progress in EOC treatment. The available evidence suggests that BRCAmt or HRD-positive is an effective biological marker for PARPi. However, in our previous clinical observation, it was found that the tumor burden may be the potential clinical markers PARPi. We intend to develop a real-world study to confirm the potential clinical markers and explore new clinical markers for PARPi.
This study intends to conduct a systematic real-world study to observe the relationship between the clinical characteristics of EOC patients and the efficacy of PARPi based on our existing research foundation and stratified analyse these correlations by BRCA and HRD status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovarian cancer patients treated with PARP inhibitors | PARP inhibitors therapy until disease progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARP inhibitors | Drug | Ovarian 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 |
| Duration of Response (DOR) | DOR is defined as the time from the first date of response until the date of first documented progression. | Through study completion, an average of 1 year |
| Disease Control Rate (DCR) | DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1. | Through study completion, an average of 1 year |
| Adverse events (AEs) | Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 to further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Ovarian cancer patients treated with PARP inhibitor in the real word.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Ni, MD | Contact | +86 13327833586 | nijingwulin@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoxiang Chen, MD,PhD | Jiangsu Cancer Institute & Hospital | Study Chair |
| Jing Ni, MD | Jiangsu Cancer Institute & Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaoxiang Chen, MD,PhD | Recruiting | Nanjing | Jiangsu | 210009 | China |
Contact Prof. Chen and Dr. Ni for primary data.
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| 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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|
| 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 |