Prospective Clinical Study of the Relationship Between Cancer Driving Mutations Found in Endometriotic Implants and the Development of Progesterone Resistance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- Number of somatic cancer driver mutations in progesterone-resistant versus progesterone-sensitive endometriosis lesions.
研究概览
简要总结
This study will test the hypothesis that the molecular changes present in ectopic endometriosis lesions correlate with progesterone-resistant disease (using the criteria defined in this study) and are present in matched eutopic endometrium.
详细描述
Tissues from 100 patients with endometriosis will be analyzed with droplet digital PCR (ddPCR) targeted sequencing and responders (n=50) will be compared to non-responders (n=50) after controlling confounding factors.
From a subset of the 100 cases, whole exome sequencing (WES) and Methylation-Specific PCR (MSP)-based methylation profiling on microdissected epithelium and stroma will be performed in matched eutopic and ectopic tissues from 20 patients with known cancer-associated mutations or 20 controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Gender: female.
- •Age: 18-45 years at the time of signing consent.
- •Clinical or surgical diagnosis of endometriosis undergoing laparoscopy.
- •Controls may not have clinical or surgical diagnosis of endometriosis.
- •Regular menstrual cycles.
- •BMI between 18-40 kg/m
- •Sexually active or have had a previous vaginal exam that used a speculum.
- •English speaking
排除标准
- •Use of any kind of steroidal therapy including oral contraceptives, Norplant, estrogen replacement/supplemental therapy, androgens (Danazol, Cyclomen, Danocrine, testosterone) or progesterone. She may not be taking or be on Celebrex.
- •Pregnant.
- •Presence of pelvic infection.
- •Mullerian anomalies with absence of a cervix.
- •History of cancer of the reproductive tract.
- •Presence of undiagnosed uterine bleeding.
- •Treatment with intrauterine device (IUD) or progestin-containing intrauterine device.
结局指标
主要结局
Number of somatic cancer driver mutations in progesterone-resistant versus progesterone-sensitive endometriosis lesions.
时间窗: Six month
Digital droplet PCR will be used to identify somatic cancer-driver mutations with the presence of at least one of KRAS or ARID1A or PIK3CA or PPP2R1A cancer-driver mutations to assess any difference between progesterone-resistant endometriosis and progesterone-sensitive endometriosis.
次要结局
- Difference in DNA methylation PCR profile of endometriotic lesions in ectopic versus eutopic endometrium in control versus diseased subjects.(One month)
- Number of cancer driver mutations in eutopic versus ectopic endometrial tissue in control versus diseased subjects(Six month)