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RecruitingNCT06695494EGGCUPUpdated Mar 25, 2026

Enabling Genomic Testing in Cancer of Unknown Primary

An observational study in Cancer of Unknown Primary and Neoplasm, Unknown Primary, sponsored by The Christie NHS Foundation Trust. Recruiting at 6 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by The Christie NHS Foundation Trust · Observational

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
16 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cancer of Unknown Primary
  • Neoplasm, Unknown Primary

Keywords

  • Cancer of unknown primary
  • Cancer
03

In context

Neoplasms, Unknown Primary

101 studies on the registry are indexed under Neoplasms, Unknown Primary; 19 are open to participants now.

This study's planned enrollment of 100 is below the median of 125 across 25 observational studies indexed under Neoplasms, Unknown Primary.

Browse Neoplasms, Unknown Primary studies →

Lead sponsor

The Christie NHS Foundation Trust is the lead sponsor of 100 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with cancer of unknown primary

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 16 years or over
  2. Written according to ICH/GCP and national regulations
  3. 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

Exclusion Criteria:

  1. Patient with an immunohistochemistry profile that provides a definitive clinical indication of a primary cancer with a specific treatment
  2. Known , , 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • All participants

    Blood sample collection for gene panel array testing and simultaneous research purposes

    Diagnostic Test: Gene panel array · Other: Blood Sample Collection

Interventions

  • Diagnostic testGene panel array

    Blood sample collection for gene panel testing

  • OtherBlood Sample Collection

    Blood sample collection for research purposes

06

What researchers measure

Primary outcomes

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

    1. Percentage of patients with adequate cfDNA yields measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints 2. Percentage of patients with actionable genomic alterations measured using FoundationOne®️ Liquid CDx testing of blood samples obtained at baseline or progression timepoints 3. 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

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

Secondary outcomes

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

    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

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

  2. Incorporate molecular genomics into routine practice

    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

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

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

    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

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

Other outcomes

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

    Collect samples to be used to investigate novel biomarkers to help in the diagnosis and treatment in 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

07

Study locations

6 of 6 sites recruiting
  • The Christie NHS Foundation Trust
    Manchester, Greater Manchester M20 4BX, United Kingdom
    Recruiting
    • Natalie Cook · Principal investigator
  • The Clatterbridge Cancer Centre NHS Foundation Trust
    Liverpool, Merseyside, United Kingdom
    Recruiting
    • Eliyaz Ahmed · Principal investigator
  • Blackpool Teaching Hospitals NHS Foundation Trust
    Blackpool, United Kingdom
    Recruiting
    • Pavel Bezecny · Principal investigator
  • Northern Care Alliance NHS Foundation Trust
    Manchester, United Kingdom
    Recruiting
    • Paul O'Donnell · Principal investigator
  • University Hospitals of Morecambe Bay NHS Trust
    Morecambe, United Kingdom
    Recruiting
    • N Chan Ton · Principal investigator
  • Lancashire Teaching Hospitals NHS Foundation Trust
    Preston, United Kingdom
    Recruiting
    • Catherine Mitchell · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06695494
Collaborators
National Institute for Health Research, United Kingdom, Hoffmann-La Roche, University of Manchester
Responsible party
Sponsor
First posted
Nov 19, 2024
Start date
Aug 15, 2024
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Mar 25, 2026

Study contacts

EGG CUP Study Team
Contact
the-christie.egg-cup@nhs.net
+44 161 918 7672
Natalie Cook
principal investigator · The University of Manchester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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