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.
Study Type
OBSERVATIONAL
Enrollment
100
Blood sample collection for gene panel testing
Blood sample collection for research purposes
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
RECRUITINGThe Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
RECRUITINGBlackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
RECRUITINGNorthern Care Alliance NHS Foundation Trust
Manchester, United Kingdom
RECRUITINGUniversity Hospitals of Morecambe Bay NHS Trust
Morecambe, United Kingdom
RECRUITINGLancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom
RECRUITINGEvaluate the utility of cfDNA molecular profiling in patients diagnosed with CUP
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
Time frame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
Data collection repository of readily available information on trails/treatments for patients diagnosed with CUP
Develop a data collection repository and readily available information on trials/treatments for patients diagnosed with CUP to be shared at monthly trial management group meetings to ensure that investigators are aware of suitable trial opportunities
Time frame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
Incorporate molecular genomics into routine practice
Routinely incorporate molecular genomics as standard of care in patients diagnosed with CUP following FoundationOne®️ CDx or FoundationOne®️ Liquid CDx at baseline and FoundationOne®️ Liquid CDx at progression
Time frame: 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
Documentation and feedback of genomic results/GTAB outcomes to all patients and treating teams following FoundationOne®️ CDx or FoundationOne®️ Liquid CDx at baseline, and FoundationOne®️ Liquid CDx at progression
Time frame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
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