MC230601 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recurrence-free survival (RFS)
研究概览
简要总结
This study seeks to better understand the recurrence of high-risk endometrial cancer. It will collect information about cancer genetics to find out various hereditary or cancer specific genetic variants that may have a role in diagnosis or management and prognosis of cancer. It also seeks to develop a genetic results and medical record databank for future studies.
详细描述
PRIMARY OBJECTIVE:
I. To generate preliminary data for a risk stratification model for recurrence including traditional histopathologic risk factors, molecular characterization in endometrial cancer patients with features of aggressive disease.
OUTLINE: This is an observational study.
Patients undergo blood and tissue sample collection and have their medical records reviewed throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Planned complete surgical staging at Mayo Clinic. Complete surgical staging includes at least total hysterectomy, bilateral salpingo-oophorectomy and lymph node assessment. Sentinel node mapping meets the criteria for lymph node assessment. Peritoneal cytology is recommended. Additional staging procedures such as pelvic and para-aortic nodal evaluation, omental biopsy or omentectomy, may also be utilized for staging in patients based on the clinical situation and at the surgeon's discretion
- •At least one preoperative or postoperative feature of aggressive disease [International Federation of Gynecology and Obstetrics (FIGO) staging used throughout this protocol]
- •Preoperatively:
- •Biopsy with grade 3 endometrioid endometrial cancer (EC) or non-endometrioid EC
- •Patients with FIGO grade 1-2 EC with evidence of extrauterine disease on imaging (CT, MRI, or PET)
- •Postoperatively:
- •Endometrial cancer (FIGO) with one or more established risk factors:
- •Non-endometrioid histology
- •Lymphovascular space invasion (LVSI), ≥ 50% of myometrial invasion, presence of isolated tumor cells (ITC) in a sentinel lymph node OR
- •Stage II to IV (FIGO) EC
- •Provide written informed consent
- •Willingness to provide mandatory blood specimens for correlative research
- •Willingness to provide mandatory tissue specimens for correlative research
- •Willingness to return to registering site for clinical follow-up
排除标准
- •Patient receiving or who has received neoadjuvant chemotherapy
- •Pre-operative pregnancy
研究组 & 干预措施
Observational
Patients undergo blood and tissue sample collection and have their medical records reviewed throughout the study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Recurrence-free survival (RFS)
时间窗: Up to 3 years
Defined as time from primary staging surgery to recurrence or death.
Presence of somatic and germline pathogenic variants
时间窗: Up to 3 years
For each participant, a surgical tissue sample (OncoExtra) and a presurgical blood sample (RiskGuard) sample will be utilized to determine the presence of somatic and germline pathogenic variants. The count and percentage of patients with the presence of somatic or germline variants will be reported by The Cancer Genome Atlas (TGCA) class. The number, type, and function of somatic variants will also be reported by TGCA class. For genes with alterations seen in at least 10 patients, a log rank test will be used to assess whether RFS differs with respect to whether an alternation is present or not.
次要结局
未报告次要终点