Enabling Genomic Testing in Cancer of Unknown Primary
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Evaluate the utility of cfDNA molecular profiling in patients diagnosed with CUP
研究概览
简要总结
Cancer of Unknown Primary (CUP) is where cancer cells are found in the body but the place the cancer began is not known. It is the 6th leading cause of cancer death in the UK and the prognosis is poor with a median survival of 6-9 months. There is a higher than average incidence of CUP in the North West (NW) of England (population of 7.4 million). Precision medicine has transformed treatment strategies in known tumour types, however in CUP there remains an urgent need to better understand CUP molecular characteristics to establish potential roles for novel therapeutic strategies. Treatment options remain limited due to difficulties in determining the primary site of the tumour and the lack of access to validated biomarkers. Access to good-quality tissue for molecular profiling remains a huge challenge in CUP. The emergence of liquid biopsies (sequence DNA in a blood test) as a source of biomarkers is also gaining rapid ground and this study aims to explore the potential utility of liquid biopsies in CUP.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 16 years or over
- •Written informed consent according to ICH/GCP and national regulations
- •ECOG Performance status 0-2
- •Confirmed diagnosis of CUP as per the ESMO guidelines. Patients must have;
- •The local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis
- •Discussion at a local CUP MDT confirming diagnosis
- •Availability of archival tumour histological report
- •Willingness to provide blood samples on up to two occasions during the study
排除标准
- •Patient with an immunohistochemistry profile that provides a definitive clinical indication of a primary cancer with a specific treatment
- •Known HIV, Hepatitis B, C positive, due to the difficulties in handling high-risk specimens
- •Patients who are unable to provide fully informed written consent
- •Presence of any medical, psychological, familial or sociological condition that, in the investigator's opinion, will hamper compliance with the study protocol and follow-up schedule
- •Bleeding diathesis (patients' on anticoagulation are permitted to enter the trial if anticoagulation can be safely managed to enable blood sampling)
- •Conditions in which blood sampling may increase risk of complications for the patients and/or investigator
结局指标
主要结局
Evaluate the utility of cfDNA molecular profiling in patients diagnosed with CUP
时间窗: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
1. Percentage of patients with adequate cfDNA yields measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints 2. Percentage of patients with actionable genomic alterations measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints 3. Percentage of patients eligible for personalised treatment options or enrolment on a UK-based clinical trial because of the cfDNA results, measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints
次要结局
- Data collection repository of readily available information on trails/treatments for patients diagnosed with CUP(33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first)
- Incorporate molecular genomics into routine practice(33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first)
- Document and feedback genomic results to treating team and patients(33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first)