Evaluation of the Clinical Utility of Circulating Biomarkers in Advanced Thyroid Carcinomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Genomic alterations
研究概览
简要总结
The study is aimed at all adult patients diagnosed with advanced thyroid carcinomas and well-differentiated thyroid carcinomas (DTC) iodine-refractory, well-differentiated iodine-refractory thyroid (RAI-R DTC) metastatic carcinomas that are candidates for systemic therapy. By simple blood sampling and analysis on peripheral blood of circulating DNA (ccf-DNA), circulating RNA (ccf-RNA), and counting and analysis of circulating tumor cells through the use of liquid biopsy, molecular profiling corresponding to those obtained by genomic sequencing on tumor tissue can be arrived at, depending on optimal therapeutic choices
详细描述
In recent years, research has focused on the so-called "liquid biopsy," understood as a noninvasive procedure capable of performing analysis on tumor-derived material contained in blood such as circulating free DNA (ccf-DNA), circulating free RNA (ccf-RNA), and circulating tumor cells (CTCs), capable of providing a dynamic snapshot of the molecular structure of the oncological pathology throughout its course.
In thyroid cancers, liquid biopsy methods have also proven feasible with potential clinical applications, both in the prognostic field, in the identification and monitoring of minimal residual disease, and in therapeutics. 28 The identification, in fact, of circulating biomarkers predictive of response or resistance to drugs in use to date first and foremost would allow in clinical practice a more accurate selection of patients at the time of initiation of systemic treatment, especially where tumor tissue is not available or adequate for molecular profiling. In addition, the identification of new molecular events, even secondary ones, during treatment would offer the possibility of developing alternative therapeutic strategies aimed at overcoming resistance.
The primary objective of the present study is to verify the match between molecular profiling obtained by liquid biopsy versus that obtained by genomic sequencing on tumor tissue (gold standard) in patients with advanced thyroid carcinoma who are candidates for systemic therapy.
The secondary objectives of this study are as follows:
- identification of circulating biomarkers predictive of response to cancer treatment useful for selecting patients with iodine-resistant metastatic disease for initiation of systemic therapy by profiling on peripheral blood;
- identification of additional molecular events, expression of polyclonal disease evolution, that may represent new therapeutic targets.
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
- •Signed written informed consent,
- •Adult (≥18 years) male or female patients
- •Histologic diagnosis of advanced thyroid carcinoma confirmed at centralized review,
- •well-differentiated thyroid carcinomas, medullary thyroid carcinomas, anaplastic thyroid carcinomas, advanced, candidates for initiation of systemic medical therapy,
- •Availability of biomolecular profiling performed by multigenic NGS panel on tumor tissue,
- •Measurable disease by conventional imaging adopted in clinical practice (total body CT with mdc, CT-PET with FDG or F-DOPA).
排除标准
- •Patients already receiving previous lines of systemic therapy,
- •Patients not eligible for systemic therapy.
结局指标
主要结局
Genomic alterations
时间窗: Before the start of pharmacologic treatment and after 30 days and 3, 6 and 24 months after the start of treatment
Presence of BRAF mutations, RAS mutations, RET mutations, rearrangements of NTRK, RET, ALK, etc. in ccf-DNA, ccf-RNA and Circulating Tumour Cells (CTCs)
次要结局
- Early metabolic response rate(30 days from the start of pharmacologic treatment)
- Overall response rate (ORR)(Throughout the study duration, an average of 24 months)
- Progression-free survival (PFS)(Throughout the study duration, an average of 24 months)
- Tumour load(Throughout the study duration, an average of 24 months)
- Number of Circulatin Tumour cells (CTC) (CTC/ml)(Before the start of pharmacologic treatment and after 30 days and 3, 6 and 24 months after the start of treatment)
- Circulatin Tumour Cells phenotype(Before the start of pharmacologic treatment and after 30 days and 3, 6 and 24 months after the start of treatment)