Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Clinical validity of ctDNA tests
研究概览
简要总结
Circulating tumor DNA assays are becoming relevant for routine diagnostics, but many related aspects are yet unresolved. With this project, the investigators aim to develop pragmatic molecular diagnostic pathways of liquid biopsies relevant in advanced gastrointestinal malignancies with focus on clinical utility and sensible use of resources. They want to evaluate the ctDNA assays on a fully automated "low-cost" multiplex platform which is already implemented in routine molecular diagnostics of solid biopsies. The project will evaluate to what extent these ctDNA assays are relevant for clinical decision-making.
详细描述
Advanced pancreatic cancer (PDAC) and cholangiocarcinoma (CCA): -Could the Idylla ctKRAS test select the ~10% of PDAC patients with KRASwt eligible for more extensive diagnostics? In PDAC and CCA, is it possible to detect patient samples with KRAS G12C or BRAF mutation for study inclusion? Could the ΔCq-value of the tests be used as a semi-quantitative tumor marker? What is the clinical value compared to the current tumor marker CA19-9?
•
Metastatic Colorectal Cancer: Are the ctDNA assays useful in detecting primary resistance and/or monitoring for secondary/acquired resistance to EGFR antibody treatment? How does the sensitivity, specificity and turnaround time of the ctDNA assays compare to tissue-based analysis? Could the Idylla ctDNA assays accelerate detection of KRAS G12C or BRAF mutations, and hence facilitate study inclusion in the first line setting? Could the ctDNA assays guide rechallenge with EGFR treatment?
Can the information of liver metastases or prognostic markers (s-CEA, s-CRP) guide timing of ctDNA sampling?
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
- •Newly referred patients with advanced pancreatic cancer (~20/year), Cholangiocarcinoma (~20/year), metastatic colorectal cancer (mCRC) (~50/year) and anti-EGFR-treated mCRC patients (~10/year) to Oslo University Hospital are eligible for inclusion.
排除标准
- 未提供
研究组 & 干预措施
Advanced gastrointestinal malignancy
Pancreatic cancer, Colorectal cancer, Cholangiocarcinoma
干预措施: Multiplex PCR-test for circulating tumor DNA (Diagnostic Test)
结局指标
主要结局
Clinical validity of ctDNA tests
时间窗: 1 week
Number of participants where the ctDNA results leads to changes in diagnostic work-up, treatment initiation or change of treatment.
次要结局
- Resources needed for ctDNA assays in routine diagnostics(1 week)
研究者
Ragnhild Nome
Principal investigator. MD, PhD
Oslo University Hospital