Endometrial Cancer Vaginal Fluid Specimen Collection Study: "ENVISION"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,200
- 试验地点
- 5
- 主要终点
- Collection of clinically characterized vaginal fluid specimens
研究概览
简要总结
This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.
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
- •Cohort 1 Participants:
- •Age ≥ 45 years, OR age ≥ 18 years with at least one risk factor
- •Diagnosed with abnormal uterine bleeding (AUB)
- •Planning standard-of-care endometrial tissue sampling to assess for endometrial cancer (EC) or atypical endometrial hyperplasia/endometrial intraepithelial neoplasia (AEH/EIN)
- •Cohort 2 Participants:
- •Age ≥ 18 years
- •Newly diagnosed, biopsy-confirmed EC or AEH/EIN
- •Planning initial management for their endometrial pathology
排除标准
- •Prior partial or complete hysterectomy
- •Current pregnancy
- •Prior pelvic or vaginal radiotherapy
- •Chemotherapy within past 5 years (except tamoxifen)
- •Any condition judged by the Investigator to preclude participation
- •Additional for Cohort 1:
- •Cancer diagnosis within past 5 years (except non-gynecologic skin cancer)
- •Current biopsy-proven cervical, vaginal, or vulvar cancer, or lower genital tract dysplasia
- •Current biopsy-proven endometrial cancer, hyperplasia, or benign polyp
- •Benign endometrial biopsy within last month
- •Additional for Cohort 2:
- •Cancer diagnosis other than EC within past 5 years (except non-gynecologic skin cancer)
- •Prior cervical cancer or biopsy-proven cervical dysplasia
- •Surgery for recurrent EC
- •Preoperative neoadjuvant chemotherapy or radiotherapy for current EC
- •Prior treatment or surgery to remove target pathology during current episode
研究组 & 干预措施
Cohort 1
Participants undergoing clinical evaluation for AUB
Cohort 2
Participants diagnosed with EC or AEH/EIN
结局指标
主要结局
Collection of clinically characterized vaginal fluid specimens
时间窗: Within 90 days of enrollment.
Vaginal fluid specimens will be collected during a standard clinical exam using a swab-based collection method. Specimens will be used for research purposes to support the development of biomarker assays. No specific biomarkers or analytical methods are defined as part of this study.
Clinical data for biomarker assay development and evaluation
时间窗: Within 90 days of enrollment
Clinical information will be collected as part of routine study participation and used to describe the study population and support research analyses. Data will be used in aggregate to contextualize research findings and inform future assay development.
Collection devices for detection
时间窗: Within 90 days of enrollment
Specimens will be collected using swab-based collection devices intended solely for specimen collection. These devices do not provide diagnostic results and are not used for clinical decision-making.
Characterization of endometrial neoplasia, other neoplasms, or underlying causes
时间窗: Within 90 days of enrollment
Characterization will be based on existing clinical assessments and diagnoses obtained through standard medical care. The study does not establish diagnostic criteria or endpoints and is intended for research and development purposes only.
次要结局
未报告次要终点