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NCT Number: NCT06695494

Enabling Genomic Testing in Cancer of Unknown Primary

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.

Recruiting

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Key information

Conditions

Cancer of Unknown Primary Neoplasm Metastasis Neoplasm, Unknown Primary Neoplasms Neoplasms, Unknown Primary Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christie NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. Patients must have;
  • The local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis
  • Discussion at a local CUP MDT confirming diagnosis
  • Availability of archival tumour histological report
  • Willingness to provide blood samples on up to two occasions during 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, 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 blood sampling)
  • Conditions in which blood sampling may increase risk of complications for the patients and/or investigator

Treatment and study plan

Gene panel array

Diagnostic Test

Blood sample collection for gene panel testing

Blood Sample Collection

Other

Blood sample collection for research purposes

Primary outcomes

  1. Evaluate the utility of cfDNA molecular profiling in patients diagnosed with CUP

    Time frame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first

    • Percentage of patients with adequate cfDNA yields measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints
    • Percentage of patients with actionable genomic alterations measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints
    • Percentage of patients eligible for personalised treatment options or enrolment on a UK-based clinical trial because of the cfDNA results, measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints

Secondary outcomes

  1. Data collection repository of readily available information on trails/treatments for patients diagnosed with CUP

    Time frame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first

    Develop a data collection repository and readily available information on trials/treatments for patients diagnosed with CUP to be shared at monthly trial management group meetings to ensure that investigators are aware of suitable trial opportunities

  2. Incorporate molecular genomics into routine practice

    Time frame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first

    Routinely incorporate molecular genomics as standard of care in patients diagnosed with CUP following FoundationOne®️ CDx or FoundationOne®️ Liquid CDx at baseline and FoundationOne®️ Liquid CDx at progression

  3. Document and feedback genomic results to treating team and patients

    Time frame: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first

    Documentation and feedback of genomic results/GTAB outcomes to all patients and treating teams following FoundationOne®️ CDx or FoundationOne®️ Liquid CDx at baseline, and FoundationOne®️ Liquid CDx at progression

Other outcomes

  1. Development of novel biomarkers to help in the diagnosis and treatment of patients diagnosed with CUP

    Time frame: Future research sample collection performed at baseline visit. 33 months of recruitment or 1st December 2026 whichever comes first

    Collect samples to be used to investigate novel biomarkers to help in the diagnosis and treatment in patients diagnosed with CUP

Study contacts

Contact information is provided by the study sponsor or research team.

EGG CUP Study Team

CONTACT

[email protected]

+44 161 918 7672

Sponsors and collaborators

Lead sponsor

The Christie NHS Foundation Trust

Other

Collaborators

  • Hoffmann-La Roche
  • National Institute for Health Research, United Kingdom
  • University of Manchester

Registry information

Acronym: EGGCUP

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 19, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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