Enabling Genomic Testing in Cancer of Unknown Primary

Launched by THE CHRISTIE NHS FOUNDATION TRUST · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding a type of cancer called Cancer of Unknown Primary (CUP), where doctors can find cancer cells in the body but cannot determine where the cancer started. CUP is serious and can be challenging to treat because doctors often lack information about the tumor's origin. The trial aims to explore a new method called liquid biopsies, which involves taking a blood sample to look for cancer-related DNA. This could help identify potential treatment options and improve the care for patients with CUP.

To participate in the study, individuals need to be at least 16 years old and have a confirmed diagnosis of CUP. They will need to provide consent and be willing to give blood samples on two occasions during the study. Participants can expect to work closely with the medical team, who will ensure they understand the process and help them throughout the trial. It's important to note that some people may not be eligible due to specific medical conditions or treatments. Overall, this trial represents an exciting opportunity to advance the understanding and treatment of CUP.

Gender

ALL

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