Enabling Genomic Testing in Cancer of Unknown Primary (EGGCUP)

March 24, 2026 updated by: The Christie NHS Foundation Trust
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with cancer of unknown primary

Description

Inclusion Criteria:

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

  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
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All participants
Blood sample collection for gene panel array testing and simultaneous research purposes
Diagnostic test: Gene panel array
Blood sample collection for gene panel testing
Other: Blood Sample Collection
Blood sample collection for research purposes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
  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
33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
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
33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
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
33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Future research sample collection performed at baseline visit. 33 months of recruitment or 1st December 2026 whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Christie NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hoffmann-La Roche
University of Manchester
National Institute for Health Research, United Kingdom

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natalie Cook, The University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CFTSp213
  • ISRCTN42910771 (Registry Identifier: International Standard Randomised Controlled Trial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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