Clinical trial NCT06695494: Enabling Genomic Testing in Cancer of Unknown Primary
Official title: Enabling Genomic Testing in Cancer of Unknown Primary
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of Unknown Primary
Neoplasm, Unknown Primary
Keywords: Cancer of unknown primary
Cancer
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Hoffmann-La Roche
name: University of Manchester
First posted: 2024-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with cancer of unknown primary

Brief summary: 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: Inclusion Criteria:

1. Aged 16 years or over
2. Written informed consent according to ICH/GCP and national regulations
3. ECOG Performance status 0-2
4. Confirmed diagnosis of CUP as per the ESMO guidelines. Patients must have;

   1. The local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis
   2. 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

Primary outcomes:
measure: Evaluate the utility of cfDNA molecular profiling in patients diagnosed with CUP
timeFrame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
Secondary outcomes:
measure: Data collection repository of readily available information on trails/treatments for patients diagnosed with CUP
timeFrame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
measure: Incorporate molecular genomics into routine practice
timeFrame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
measure: Document and feedback genomic results to treating team and patients
timeFrame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
Other outcomes:
measure: Development of novel biomarkers to help in the diagnosis and treatment of patients diagnosed with CUP
timeFrame: Future research sample collection performed at baseline visit. 33 months of recruitment or 1st December 2026 whichever comes first
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
city: Liverpool
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
state: Merseyside
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Northern Care Alliance NHS Foundation Trust
city: Morecambe
country: United Kingdom
facility: University Hospitals of Morecambe Bay NHS Trust
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: The University of Manchester
name: Natalie Cook
role: PRINCIPAL_INVESTIGATOR
References: