Cancers of unknown primary (CUP) Cancer
Conditions
Interventions
CUP patients will be identified as eligible for the trial by the Sussex Hospitals MDT and will be invited to participate in the study. Following recruitment and full consenting of the patient, the res
Sponsors
University of Sussex
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Written informed consent according to International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (ICH/GCP) and national regulations 3. ECOG Performance status 0-2 4. Suspected diagnosis of CUP as per the European Society for Medical Oncology (ESMO) guidelines, or presenting with a MOU 5. Well enough for biopsy 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 Multidisciplinary Team (MDT) suspecting diagnosis 3. Availability of tumour histological report
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients identified as eligible and invited to participate that provide written consent for AI analysis of their tumour samples, measured using study screening and consent logs as a percentage of eligible patients invited to participate, at monthly intervals from month 1 to month 12;Proportion of consented tumour samples containing sufficient tumour content and material to proceed to DNA and RNA sequencing, measured using pathology assessment reports and sequencing laboratory records as a percentage of consented tumour samples, at monthly intervals from month 1 to month 24;Proportion of sequenced samples that are fully analysed by the AI pipeline, measured using AI pipeline processing records as a percentage of sequenced tumour samples, at monthly intervals from month 1 to month 24;Proportion of fully analysed samples in which the AI pipeline identifies an actionable target with a licensed precision therapy, measured using AI pipeline outputs and molecular analysis reports as a percentage of fully analysed tumour samples, at monthly intervals from month 1 to month 24;Proportion of fully analysed samples in which the AI pipeline identifies one or more potential clinical trials for which the patient may be eligible, measured using AI pipeline clinical trial matching reports as a percentage of fully analysed tumour samples, at monthly intervals from month 1 to month 24;Proportion of sequenced samples that are fully analysed by the AI pipeline and a tissue type identified, measured using AI tissue-of-origin prediction reports as a percentage of sequenced tumour samples, at monthly intervals from month 1 to month 24;Assessment of optimisation of the diagnostic workflow for cancers of unknown primary (CUP) through incorporation of genomic sequencing and AI-derived data, measured using an end-of-study evaluation of study process metrics, genomic sequencing results, AI outputs and multidisciplinary team review, at at month 24 | — |
Countries
England, United Kingdom
Contacts
Public ContactFrances Pearl
Outcome results
None listed