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Homologous recombination deficiency (HRD) is an important biomarker of poly (ADP-ribose) polymerase inhibitor (PARPi) in patients with high-grade serous ovarian cancer (HGSOC). The stability of HRD in the recurrent HGSOC and its primary pair remains unknown.
This study intends to perform HRD testing of ovarian cancer in the recurrent HGSOC and its primary pair, furtherly correlate HRD status and clinical characteristics in the recurited population.
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| Measure | Description | Time Frame |
|---|---|---|
| Loss of heterozygosity (LOH) score in the primary and recurrent ovarian cancer | The LOH score is a scale describing the genomic loss of heterozygosity status in the primary or recurrent tumor of an ovarian cancer patient. The score is determined by analyzing more than 3500 SNPs spaced at 1Mb intervals across the genome on the FoundationOne CDx test and extrapolating an LOH profile, excluding arm and chromosome-wide LOH segments. The score is summarized as the percentage of the genome with LOH regions. | Through study completion, an average of 1 year] |
| Homologous recombination deficiency (HRD) status | The HRD status for primary or recurrent tumor in a patient is considered according to the LOH score and genomic mutation status of BRCA1 and BRCA2 genes in the sample. A sample with LOH≥16%，and/or with genomic mutation in BRCA1 or BRCA2 gene, is defined as HRD positive. Otherwise, a sample with LOH<16% and wild type BRCA1/BRCA2 genes is defined as HRD negative. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival in recruited patients | From the beginning of the patient's onset, an average of 1 year |
| Overall survival | Overall survival in recruited patients |
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Inclusion Criteria:
Exclusion Criteria:
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Platinum-sensitive relapsed high-grade serous ovarian cancer patients undergoing secondary cytoreductive surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Ni, MD | Contact | +86 13327833586 | nijingwulin@126.com | |
| Xiaoxiang Chen, MD,PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoxiang Chen Chen, MD,PhD | Jiangsu Cancer Institute & Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaoxiang Chen | Nanjing | Jiangsu | 210009 | China |
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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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The formalin fixation and paraffin embedding (FFPE ) samples from the primary and secondary cytoreductive surgery will be obtained after patients' informed consent.
| From the beginning of the patient's onset, an average of 3 year |
| 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 |