Enabling Genomic Testing in Cancer of Unknown Primary

NCT06695494 | Recruiting

• 2 other identifiers: CFTSp213ISRCTN42910771
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Cancer of Unknown Primary; Neoplasm, Unknown Primary

Keywords

Cancer of unknown primary; Cancer

Outcome Measures

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

  33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first

Secondary Outcomes (3)

• Data collection repository of readily available information on trails/treatments for patients diagnosed with CUP

  33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first

• Incorporate molecular genomics into routine practice

  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

  33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first

Other Outcomes (1)

• Development of novel biomarkers to help in the diagnosis and treatment of patients diagnosed with CUP

  Future research sample collection performed at baseline visit. 33 months of recruitment or 1st December 2026 whichever comes first

Study Arms (1)

All participants

Blood sample collection for gene panel array testing and simultaneous research purposes

Diagnostic Test: Gene panel array; Other: Blood Sample Collection

Interventions

Gene panel array DIAGNOSTIC_TEST

Blood sample collection for gene panel testing

All participants

Blood Sample Collection OTHER

Blood sample collection for research purposes

All participants

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with cancer of unknown primary

You may qualify if:

• 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;
• The local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis
• Discussion at a local CUP MDT confirming diagnosis
• Availability of archival tumour histological report
• Willingness to provide blood samples on up to two occasions during the study

You may not qualify if:

• 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
• Bleeding diathesis (patients' on anticoagulation are permitted to enter the trial if anticoagulation can be safely managed to enable blood sampling)
• Conditions in which blood sampling may increase risk of complications for the patients and/or investigator

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Hoffmann-La Roche: collaborator
• University of Manchester: collaborator

Study Sites (6)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, Merseyside, United Kingdom

RECRUITING

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, United Kingdom

RECRUITING

Northern Care Alliance NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

University Hospitals of Morecambe Bay NHS Trust

Morecambe, United Kingdom

RECRUITING

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for genetic analysis

MeSH Terms

Conditions

Neoplasms, Unknown Primary; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Natalie Cook

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

EGG CUP Study Team

CONTACT

+44 161 918 7672; the-christie.egg-cup@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: November 19, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

GB (6)