Official Title
Carcinoma of Unknown Primary (CUP): a Comparison Across Tissue and Liquid
Brief Title
Carcinoma of Unknown Primary (CUP): a Comparison Across Tissue and Liquid Biomarkers
Protocol ID
NCT04750109
Lead Sponsor
The Christie NHS Foundation Trust
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 has a poor prognosis; it is the 6th most common cause of
cancer death in the UK.
To date there have been limited studies investigating molecular genomics in CUP patients,
resulting in limited evidence to evaluate whether genomic profiling has added value over
and above the standard diagnostics provided in the NHS.
As a result, our project will aim to;
- Assess genomic sequencing (both in tissue and blood) for the diagnosis and treatment
guidance in CUP patients including a comparison of the effectiveness of tissue and
blood based biomarkers
- Collect evidence to further develop technology that predicts an individual's
response to a treatment
- Develop innovative systems of clinical data capture in patients with CUP
- Investigate novel biomarkers to determine the primary tumour location Approximately
120-140 CUP patients will be recruited across 7 UK NHS sites. Tumour samples will be
collected from patients undergoing a standard of care procedure OR medically fit
patients with accessible tumour. Archival tumour may also be obtained. Some samples
will be stored for future translational research.
Sequencing results alongside clinical data will be discussed by a multi-disciplinary CUP
Molecular Tumour Board. They will provide oversight on the nature, clinical significance
and relevance of the results. They will inform the local CUP team of any "actionable"
genetic changes, which could potentially direct selection of a targeted therapy trial for
that patient. Sequential blood samples will be collected to investigate genetic
characteristics that may be able to predict response to therapy.
The aggregated anonymised data will be made publicly available following completion of
this trial.
Study Period
-
Enrollment Count
117 participants
Eligibility Criteria
Inclusion Criteria:
- 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;
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
- 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 Criteria:
- 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
Filters
Cancer of Unknown Primary Site
COMPLETED
CHILD
ADULT
OLDER_ADULT