NCT06809673Enrolling By Invitation不适用
PA.RI.GE. Study. The Prognostic Role of Inflammatory Circulating Biomarkers in HNSCC: a Prospective Multicentric Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- To identify a profile of circulating biomarkers in patients affected by HNSCC
研究概览
简要总结
This is a clinical, observational, non-pharmacological, multicenter, prospective case-control no-profit study to assess the prognostic role of several circulating inflammatory biomarkers
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years;
- •Written informed consent;
- •Squamous carcinoma of the hypopharynx, larynx and oral cavity;
- •Clinical stage I-IVa according to the VIII edition of AJCC staging system
- •Primary surgery as first line curative intent treatment, followed by ± adjuvant radiotherapy± chemotherapy based on the pathological findings following the NCCN guidelines
排除标准
- •Relapsing or metastatic disease
- •Locally advanced disease not amenable to curative intent treatment
- •Previous local or systemic treatment for head and neck cancer
- •Previous malignancies (exluding non-melanoma skin cancers) unless complete remission has been achieved at least 5 years before entering the study
- •Psychiatric disorder or known substance abuse
- •Concomitant immunosuppressive treatment
- •Concomitant immunostimulant treatment
- •Chronic inflammatory disease
- •Autoimmune disease
- •Major surgery in the previous year
- •History of recent onset of any condition which, in the investigator's opinion, could interfere with patient adherence for the entire duration of the protocol.
- •Positive serum pregnancy test for women of childbearing age. Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal.
结局指标
主要结局
To identify a profile of circulating biomarkers in patients affected by HNSCC
时间窗: 72 months
To identify a subset of patients in which biomarkers modifications might anticipate disease recurrence
时间窗: 72 months
次要结局
未报告次要终点
研究者
Filippo Marchi
Dr
Ospedale Policlinico San Martino
研究点 (1)
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