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Carcinoma of Unknown Primary (CUP): a Comparison Across Tissue and Liquid Biomarkers

NCT04750109 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 117

Last updated 2024-10-10

No results posted yet for this study

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.

Conditions

  • Cancer of Unknown Primary Site

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Concr

    collaborator INDUSTRY

  • Durham University

    collaborator OTHER

  • The Christie NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-09
Primary Completion
2024-06-28
Completion
2024-06-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04750109 on ClinicalTrials.gov