Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine: A Tumour Agnostic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The number (%) of patients in whom ctDNA result was deemed to be clinically useful at the time of progression on prior line of therapy
研究概览
简要总结
ctDNA stands for circulating tumour DNA. As ctDNA is released by tumour cells into the blood stream, taking a blood sample and analysing it for ctDNA, can provide a lot of useful information about a patient's cancer. In certain situations, ctDNA can be used to screen for or detect cancer early, to aid clinical decisions about which treatment to give a patient, to provide information about if a cancer has become resistant to treatment, or provide information about how much cancer may be left after treatment (residual disease).
The aim of this trial is to establish the clinical utility of implementing ctDNA testing in cancer patients with a view to enhance the delivery of personalised care within the National Health Service in the United Kingdom (UK).
One hundred patients will be recruited, with 20 from each of the following cancer types:
- Non-small cell lung cancer
- Gastrointestinal stromal tumours
- Colorectal cancer
- Biliary tract cancer
- Ovarian cancer.
Patients must be aged 18 or over, must have had progressive disease whilst receiving anti-cancer treatment, and must be being treated at The Royal Marsden.
Patients will have a blood sample taken and analysed using the Marsden360 ctDNA test. The results of the test will be looked at by The Royal Marsden Genomic Tissue Advisory Board (GTAB), and for each individual patient, the GTAB will determine if having a ctDNA test helped to personalise their care by:
- Aiding the identification of a genomically-matched standard of care therapy
- Aiding the identification of a genomically-matched clinical trial (based in the UK)
- Offering additional prognostic information not otherwise available through standard of care testing
- Negating the need for a tissue biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •All cohorts:
- •Age ≥18 years old
- •Ability to provide written informed consent
- •Presence of metastatic or unresectable disease
- •Being reviewed and treated through medical oncology service at Royal Marsden Hospital
- •Cohort 1: Locally Advanced/Metastatic NSCLC
- •Oncogene-addicted NSCLC (i.e. ESCAT Tier 1 oncogenic drivers: EGFR/ALK/ROS1/RET/MET/BRAF/NTRK/HER2/KRAS), AND
- •Progressive disease on targeted therapy (any line) within the 6 weeks prior to consent
- •Cohort 2: Locally Advanced/Metastatic GIST
- •Locally advanced/metastatic gastrointestinal stromal tumour (GIST), AND
- •Progressive disease on targeted therapy (any line) within the 6 weeks prior to consent
- •Cohort 3: Metastatic Colorectal Cancer
- •Metastatic colorectal cancer, left sided, RAS wild type, HER2 any status, AND
- •If HER2 negative or unknown: progressive disease on systemic anti-cancer therapy (SACT) with an anti-EGFR agent (e.g. cetuximab) within the 6 weeks prior to consent
- •If HER2 positive: progressive disease on first line systemic anti-cancer therapy (SACT) +/- an anti-EGFR agent within the 6 weeks prior to consent
- •Cohort 4: Locally Advanced/Metastatic BTC
- •Identified targetable mutation (IDH1 mutation/HER2 amplification/FGFR2 fusion or rearrangement/NTRK fusion/BRAF V600E mutation/MMR deficiency [dMMR]), AND
- •Progressive disease on targeted therapy (any line) demonstrated within the 6 weeks prior to consent
- •Cohort 5: Advanced/Metastatic ovarian cancer
- •Diagnosis of advanced/metastatic high-grade ovarian cancer, AND
- •Known BRCA status, AND
- •Progressive disease on a PARP-inhibitor (with or without bevacizumab) following platinum-based therapy in the 1st line maintenance setting, within the 6 weeks prior to consent
排除标准
- •All cohorts:
- •Medically unstable to commit to sampling required for the study
- •ECOG performance status ≥3
研究组 & 干预措施
Patients who have had progressive disease on therapy within the 6 weeks prior to consent
干预措施: Marsden360 ctDNA test and GTAB review (Diagnostic Test)
结局指标
主要结局
The number (%) of patients in whom ctDNA result was deemed to be clinically useful at the time of progression on prior line of therapy
时间窗: From the date of enrolment plus 6 weeks
This is a composite outcome measure, where the results of ctDNA testing performed at the time of progressive disease led to at least one of the following (to be determined by the GTAB): * Identification of a genomically-matched SOC therapy, or * Identification of a genomically-matched clinical trial (based in the UK), or * Offered additional prognostic information not otherwise available through SOC, or * Negated the need for a tissue biopsy
次要结局
- Patients in whom ctDNA result identified a genomically-matched SOC therapy(From the date of enrolment plus 6 weeks)
- Patients in whom ctDNA result identified a genomically-matched clinical trial (based in the UK)(From the date of enrolment plus 6 weeks)
- Patients in whom ctDNA result offered additional prognostic information not otherwise available through SOC testing(From the date of enrolment plus 6 weeks)
- Patients in whom ctDNA result negated need for tissue biopsy(From the date of enrolment plus 6 weeks)