Variance of HRD From Primary to Recurrent in High-grade Serous Ovarian Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Loss of heterozygosity (LOH) score in the primary and recurrent ovarian cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects join the study voluntarily and sign informed consent;
- •Female subjects are older than 18 years;
- •ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
- •Life expectancy≥3 months;
- •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 histology
排除标准
- •Personnel involved in the formulation or implementation of the research plan;
- •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;
结局指标
主要结局
Loss of heterozygosity (LOH) score in the primary and recurrent ovarian cancer
时间窗: Through study completion, an average of 1 year]
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.
Homologous recombination deficiency (HRD) status
时间窗: Through study completion, an average of 1 year
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.
次要结局
- Progression-free survival(From the beginning of the patient's onset, an average of 1 year)
- Overall survival(From the beginning of the patient's onset, an average of 3 year)
研究者
Xiaoxiang Chen
Academic secretary of gynecological oncology Committee of Jiangsu anti cancer association
Jiangsu Cancer Institute & Hospital