NCT06695494 Enabling Genomic Testing in Cancer of Unknown Primary
| NCT ID | NCT06695494 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Christie NHS Foundation Trust |
| Condition | Cancer of Unknown Primary |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-08-15 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Natalie Cook
PRINCIPAL INVESTIGATOR
The University of Manchester
Frequently Asked Questions
Who can join the NCT06695494 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Cancer of Unknown Primary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06695494 currently recruiting?
Yes, NCT06695494 is actively recruiting participants. Contact the research team at the-christie.egg-cup@nhs.net for enrollment information.
Where is the NCT06695494 trial being conducted?
This trial is being conducted at Manchester, United Kingdom, Liverpool, United Kingdom, Blackpool, United Kingdom, Manchester, United Kingdom and 2 additional locations.
Who is sponsoring the NCT06695494 clinical trial?
NCT06695494 is sponsored by The Christie NHS Foundation Trust. The principal investigator is Natalie Cook at The University of Manchester. The trial plans to enroll 100 participants.
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.