NCT05462951已完成不适用
Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
Denise Fabian2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2023年1月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Biomarker
研究概览
简要总结
This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.
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
- •- Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone.
排除标准
- •Presence of another concurrent active invasive malignancy
- •Prior invasive malignancy diagnosed within the last three years except for [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix
- •prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.
研究组 & 干预措施
Radiochemotherapy followed by brachytherapy
Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy
干预措施: Standard (Radiation)
结局指标
主要结局
Biomarker
时间窗: 3 months posttherapy
deoxyribonucleotide levels
次要结局
未报告次要终点
研究者
Denise Fabian
Assistant Professor
University of Kentucky
研究点 (2)
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