Enabling Genomic Testing in Cancer of Unknown Primary

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorThe Christie NHS Foundation Trust

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Gene panel array
  • Blood Sample Collection

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

The Christie NHS Foundation Trust

Lead sponsor

National Institute for Health Research, United Kingdom

Collaborator

Hoffmann-La Roche

Collaborator

University of Manchester

Collaborator