Cancer of Unknown PrimaryEGGCUPNCT06695494
Enabling Genomic Testing in Cancer of Unknown Primary
An observational study of Cancer of Unknown Primary and Neoplasm, Unknown Primary, run by The Christie NHS Foundation Trust at 6 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer of Unknown Primary, Neoplasm, Unknown Primary
- What is being tested?
- Gene panel array and Blood Sample Collection
- How many people
- 100 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 15 Aug 2024to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with cancer of unknown primary
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United Kingdom6 sites, 6 recruiting
- Recruiting
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool
Pavel Bezecny
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, Merseyside
Eliyaz Ahmed
- Recruiting
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
Natalie Cook
- Recruiting
Northern Care Alliance NHS Foundation Trust
Manchester
Paul O'Donnell
- Recruiting
University Hospitals of Morecambe Bay NHS Trust
Morecambe
N Chan Ton
- Recruiting
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
Catherine Mitchell
About this study
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.
- Being tested
- Gene panel array, Blood Sample Collection
- Keywords
- Cancer of unknown primary, Cancer
- Medical subject headings
- Neoplasms, Unknown Primary, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene panel arrayDiagnostic test
Blood sample collection for gene panel testing
Blood Sample CollectionOther
Blood sample collection for research purposes
| Study group | Role | What they receive |
|---|---|---|
| All participants | Blood sample collection for gene panel array testing and simultaneous research purposes Receives: Diagnostic Test: Gene panel array; Other: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the utility of cfDNA molecular profiling in patients diagnosed with CUP
- 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
Measured: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
Secondary outcomes (3)
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
Measured: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
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
Measured: 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
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
Measured: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start15 Aug 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Unknown PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Hoffmann-La Roche, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Natalie Cook, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695494
- Sponsor's protocol ID
- CFTSp213
- Other IDs
- ISRCTN42910771
- Acronym
- EGGCUP
- Status last verified
- Mar 2026
- First submitted
- 27 Aug 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Genomic Testing in Cancer of Unknown Primary
- ClinicalTrials.gov ID
- NCT06695494
- Acronym / sponsor ID
- EGGCUP / CFTSp213
- Keywords
- Cancer of unknown primary, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Hoffmann-La Roche, University of Manchester
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Diagnostic Test: Gene panel array, Other: Blood Sample CollectionBlood sample collection for gene panel array testing and simultaneous research purposes |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with cancer of unknown primary
Key inclusion criteria (8 listed)
- 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;
- Availability of archival tumour histological report
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gene panel arrayBlood sample collection for gene panel testing | Diagnostic test | All participants |
| Blood Sample CollectionBlood sample collection for research purposes | Other | All participants |
Primary outcome
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
3 secondary outcomes
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
Incorporate molecular genomics into routine practice
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
Related trials for Cancer of Unknown Primary
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Smartphone-Based Self-Registration of Health Data in Patients With Severe Unspecific Symptoms or Cancer of Unknown Primary
Advanced Unspecific Symptom, Cancer of Unknown Primary Site
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Cook principal investigator
The University of Manchester
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Unknown Primary and Neoplasm, Unknown Primary, run by The Christie NHS Foundation Trust at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EGG CUP Study Team (+44 161 918 7672, the-christie.egg-cup@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.