Status:
COMPLETED
Carcinoma of Unknown Primary (CUP): a Comparison Across Tissue and Liquid Biomarkers
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborating Sponsors:
Hoffmann-La Roche
Concr
Conditions:
Cancer of Unknown Primary Site
Eligibility:
All Genders
16+ years
Brief Summary
Patients with Carcinoma of Unknown Primary (CUP) have widespread cancer at diagnosis however the specific site of origin cannot be found, despite significant testing, making it difficult to treat. CUP...
Eligibility Criteria
Inclusion
- 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 (described above). 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
- Accessible tumour that can be safely biopsied using radiological techniques. Biopsy may be undertaken as standard of care (surplus tissue sample to be used for this protocol), or maximum of one fresh biopsy specifically for purposes of the protocol. Subjects with inaccessible tumours for biopsy specimens but with a confirmed CUP diagnosis, may be enrolled without a biopsy upon consultation and agreement by the sponsor
- Availability of archival tumour sample, slides and histological report
- Willingness to provide blood samples on up to three occasions during the course of the study
Exclusion
- 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, or COVID-19 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 fresh tumour biopsies and blood sampling)
- Conditions in which research biopsies or blood sampling may increase risk of complications for the patients and/or investigator
Key Trial Info
Start Date :
June 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 28 2024
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT04750109
Start Date
June 9 2021
End Date
June 28 2024
Last Update
October 10 2024
Active Locations (7)
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1
UCL Cancer Institute
London, London, United Kingdom, WC1E 6BT
2
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom, BA1 3NG
3
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
4
Edinburgh Cancer Centre
Edinburgh, United Kingdom, EH4 2XR