NCT06321627招募中不适用
Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach - ICARUS Project
European Institute of Oncology1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年4月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
The purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of Human Papilloma Virus (HPV) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body.
详细描述
The present study (ICARUS - genomIC RAdiosensitivity viRUS) involves the collection of data (retrospective and prospective) from an extensive cohort of patients with HPV-related tumors of the oropharynx, cervix, and anus.
The aim is to:
- investigate the role of Cl2 in non-oropharyngeal HPV-related tumors, and
- compare the Radiation Sensitivity Index (RSI) values of HPV-related tumors in patients who responded to radiotherapy (responders) with those of patients with radioresistant tumors (non-responders).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years old)
- •Diagnosis of HPV-related squamous cell carcinomas of the oropharynx, uterine cervix, and anus
- •Curative intent radiation therapy (exclusive, post-operative, with or without chemotherapy)
- •Availability of pre-radiation therapy biopsy sample
- •No diagnosis of solid neoplasms and/or hematologic malignancies in the previous 5 years
- •Possibility of retrospective and prospective data collection and anonymous submission to the referring center of clinical data related to the patient, pathology, and treatment characteristics (including radiation treatment plan in RT.dose format)
- •Ability to obtain written informed consent for the use of data anonymously for research purposes
排除标准
- •Patients undergoing surgical treatment
- •Patients with local and/or locoregional recurrence
- •Patients with synchronous distant metastases at diagnosis
- •Patients previously treated with oncologic therapies for tumors of the same anatomical site
结局指标
主要结局
Disease free survival
时间窗: 5 years
Number of patients with a recurrence (local or distant) after 5 years
次要结局
- Genetic patterns of radiosensitivity(1 year)
研究者
研究点 (1)
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