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
This trial does not accept healthy volunteersQualifiers
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 population
Patients diagnosed with cancer of unknown primary
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Gene panel array
Diagnostic testBlood sample collection for gene panel testing
Blood Sample Collection
Other interventionBlood sample collection for research purposes
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: All participants2 interventions
Trial outcomes
Primary outcomes
1
Evaluate 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 firstSecondary outcomes
1
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 first2
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 first3
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 firstOther outcomes
1
Development of novel biomarkers to help in the diagnosis and treatment of patients diagnosed with CUP
Collect samples to be used to investigate novel biomarkers to help in the diagnosis and treatment in patients diagnosed with CUP
Time frame
Future research sample collection performed at baseline visit. 33 months of recruitment or 1st December 2026 whichever comes firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Christie NHS Foundation Trust
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
Hoffmann-La Roche
Collaborator
University of Manchester
Collaborator
Source ClinicalTrials.gov