Pilot Study to Describe the Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Torquetenovirus in numbers of copies/ml
研究概览
简要总结
The aim of this project is to descriptively explore the trend of torquetenovirus viral load TTV during therapy with immune checkpoint inhibitor ICI in these patients, to evaluate a possible role of this virus as a biomarker of response.
详细描述
The study involves the prospective recruitment of patients with metastatic clear cell renal cell carcinoma who begin a first line of treatment with immunotherapy at the UOC of Medical Oncology 1 of the Regina Elena Cancer Institute in Rome. Participants will undergo the following extra-clinical procedures and provided for by the protocol:
- Explanation, reading and signing of the informed consent;
- Performing a blood sample (approximately 7 ml);
- Collection of fecal material at different timepoints. It should be noted that the procedures necessary for conducting the study will not affect the diagnostic and therapeutic process of the patients and will only have research purposes.
The biological material collected, appropriately labeled, processed at the reference laboratories, where it will be used to perform the planned analyses. Blood and/or stool samples will be collected at different timepoints:
- Time zero (T0): before the start of therapy (blood and stool)
- C2 (T1): before the start of cycle 2 (blood)
- C4 (T2): after cycle 4, i.e. coinciding with the first radiological reassessment (blood and stool)
- 22W or 19W (T3): after 12 weeks from C4 i.e. coinciding with the radiological reassessments (blood and stool), i.e. at the last timepoint of this study.
Additional blood sampling will be performed in the case of immune-related toxicity (≥ G2 according to CTCAE) requiring steroid administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients over 18 years of age;
- •Histological diagnosis of clear cell renal cell carcinoma;
- •Evidence of advanced or metastatic disease;
- •Patients diagnosed with metastatic clear cell renal cell carcinoma about to start first-line immunotherapy (ICI + ICI or ICI + TKI);
- •Patients able to comply with the study procedures.
- •Patients who give written informed consent personally or through a witness (study participation and data processing), before any study-specific procedure is started.
排除标准
- •Previous neoplasms;
- •Previous antineoplastic treatments;
- •Previous steroid treatments;
- •Active viral infections (e.g., HCV, HIV, etc.);
- •Lack of autonomy in adhering to study procedures.
结局指标
主要结局
Torquetenovirus in numbers of copies/ml
时间窗: 24 months
To descriptively evaluate the trend of torquetenovirus TTV viral load measured in number of copies/milliliter using a quantitative method, i.e. a REAL TIME PCR, during treatment with immunotherapy in patients with metastatic clear cell renal cell carcinoma starting a first-line treatment.
次要结局
- Microbiome assessment(24 months)