Egg-Cup

Trial Info

Status: Open

Specialty: Multiple

Date Opened: 12/12/2024

Planned Close Date: 31/12/2026

Sponsor: The Christie NHS Foundation Trust

Principal Investigator: Dr Chan Ton

Study Title: Enabling Genomic Testing in Cancer of Unknown Primary (EGG-CUP)

Trial Description

Cancers of Unknown Primary (CUP) are an important but historically under-researched clinical entity. CUP is the 6th leading cause of cancer death in the UK and 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). Here we intend to focus only the North West to ensure we can facilitate and establish pathways across the region.

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 research aims to explore the potential utility of liquid biopsies in CUP.

Here, we plan to offer liquid biopsies to approximately 100 patients. Based upon the molecular changes we will determine if there is a specific cancer type and identify actionable molecular changes.

The NHS Genomic Medicine Service are supportive of this research. We will incorporate genomic findings into standard of care discussions through NHS genomic laboratory hubs. This study will feed into the NHS Genomics Medicines Service via the North-West Genomics laboratories. The genomic and clinical data that will be collected could be used to drive additional research in the UK. It would address an area of high unmet need and has the potential to change clinical care.

Inclusion Criteria

1. Aged 16 years or over

2. Written informed consent according to GCP and national regulations

3. ECOG Performance status 0-2

4. Confirmed diagnosis of CUP as per the ESMO guidelines. Patients must have;

a. The local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis

b. Discussion at a local CUP MDT confirming diagnosis

5. Availability of archival tumour histological report.

6. Willingness to provide blood samples on up to two occasions during the study

Exclusion Criteria

1. Patient with an immunohistochemistry profile that provides a definitive clinical indication of a primary cancer with a specific treatment

2. Known HIV, Hepatitis B, C positive, due to the difficulties in handling high-risk specimens

3. Patients who are unable to provide fully informed written consent

4. 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

5. Bleeding diathesis (patients’ on anticoagulation are permitted to enter the trial if anticoagulation can be safely managed to enable blood sampling)

6. Conditions in which blood sampling may increase risk of complications for the patients and/or investigator

Contacts

Research Nurse: Hilary Thatcher

Administrator: research.oncology@mbht.nhs.uk

Link to EDGE

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