Exploring genomic testing for cancer of unknown primary
Enabling Genomic Testing in Cancer of Unknown Primary
This study is testing if genomic testing can help find the hidden source of cancer in patients with Cancer of Unknown Primary to improve treatment options and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | The Christie NHS Foundation Trust Academic / other |
| Locations | 6 sites (Manchester, Greater Manchester and 5 other locations) |
| Trial ID | NCT06695494 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with Cancer of Unknown Primary (CUP), a condition where the origin of cancer is not identified. The study aims to enhance understanding of the molecular characteristics of CUP through genomic testing, including the use of gene panel arrays and blood sample collection for liquid biopsies. By analyzing these samples, researchers hope to identify potential biomarkers that could lead to novel therapeutic strategies. The study addresses the challenges of limited treatment options and aims to improve patient outcomes in this difficult-to-treat cancer type.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16 years or older with a confirmed diagnosis of CUP and the ability to provide informed consent.
Not a fit: Patients with a definitive diagnosis of a primary cancer that has specific treatment options or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment options for patients with cancer of unknown primary.
How similar studies have performed: While the approach of using genomic testing in CUP is gaining traction, this specific study represents a novel effort to systematically explore its utility in this patient population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Manchester, Greater Manchester and 5 other locations
- The Christie NHS Foundation Trust — Manchester, Greater Manchester, 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)
Study contacts
- Principal investigator: Natalie Cook — The University of Manchester
- Study coordinator: EGG CUP Study Team
- Email: the-christie.egg-cup@nhs.net
- Phone: +44 161 918 7672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.