Molecular Biomarkers Predicting Early Development of Endometrial Carcinoma: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Mutation analyses on matched samples from female patients with a previous endometrial biopsy negative for cancer, followed by a subsequent biopsy positive for cancer
研究概览
简要总结
Endometrial carcinoma represents the most common gynaecological cancer and the sixth most frequent cancer among women worldwide. The 5-year survival of patients with stage I endometrial carcinoma is 75%-88% versus 50% for stage III or 15% for stage IV disease. Therefore, early detection could improve survival rates. Specifically, in the most prevalent, type 1 endometrial cancer develops from hyperplastic endometrium. The aim of the study was to evaluate the utility of cancer gene mutations from endometrial biopsies towards predicting synchronous or metachronous development of malignant lesions. The aim of the study was to evaluate whether endometrial biopsies could already carry mutations in cancer genes useful for predicting or anticipating subsequent cancer development
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
- •age > 18 years old
- •patients subjected to endometrial biopsies with previous histopathologically negative and subsequent histopathologically positive for endometrial carcinoma
- •patient informed consent
排除标准
- •Endometrial carcinoma patients without a previous non-tumour biopsy were excluded
结局指标
主要结局
Mutation analyses on matched samples from female patients with a previous endometrial biopsy negative for cancer, followed by a subsequent biopsy positive for cancer
时间窗: 1 year
Mutation analyses performed on DNA isolated from formalin fixed, paraffin embedded samples retrieved for each patient by sequencing a panel of fifty genes (ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, EZH2, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, JAK2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, VHL) both on non-cancerous biopsies and on matched endometrial carcinoma biopsies.
次要结局
- Integration of molecular results with clinico pathological data(1 year)
研究者
Gennaro Scutiero
Principal Investigator
Università degli Studi di Ferrara