Actively Recruiting
Enabling Genomic Testing in Cancer of Unknown Primary
Led by The Christie NHS Foundation Trust · Updated on 2026-03-25
100
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
The Christie NHS Foundation Trust
Lead Sponsor
N
National Institute for Health Research, United Kingdom
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying Cancer of Unknown Primary (CUP), a condition where cancer cells are present but the original tumor site is unknown. CUP is a common cause of cancer death with limited treatment options and a poor prognosis. This research aims to better understand the molecular characteristics of CUP by exploring the use of liquid biopsies, which analyze DNA from blood samples, as a new way to identify biomarkers and guide potential therapies. Participants will provide blood samples for gene panel array testing and research purposes. This study involves collecting blood on up to two occasions to perform molecular profiling. The study will recruit for 33 months, followed by a 12-month follow-up period or until December 1, 2027, whichever comes first. The goal is to assess how useful cell-free DNA (cfDNA) profiling is for patients with CUP and to integrate molecular genomics into routine clinical practice. During the study, participants will be monitored through collection of blood samples and their tumor histological reports will be reviewed. Data about treatments and trials for CUP will be gathered and genomic results will be shared with treating teams and patients. The study is observational and involves no experimental treatments. Participants are expected to consent and have an ECOG performance status of 0 to 2, allowing them to undergo blood sampling and follow-up over the course of the study.
CONDITIONS
Brief Title
Enabling Genomic Testing in Cancer of Unknown Primary
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 16 years or older
- Written informed consent according to ICH/GCP and national regulations
- ECOG Performance status 0-2
- Confirmed diagnosis of Cancer of Unknown Primary (CUP) per ESMO guidelines including pathology reports and multidisciplinary team confirmation
- Availability of archival tumor histological report
- Willingness to provide blood samples on up to two occasions during the study
You will not qualify if you...
- Immunohistochemistry profile indicating a definitive primary cancer with specific treatment
- Known positive status for HIV, Hepatitis B, or Hepatitis C
- Unable to provide fully informed written consent
- Medical, psychological, familial, or sociological conditions that may impair compliance with study protocol and follow-up
- Bleeding disorders unless anticoagulation can be safely managed for blood sampling
- Conditions increasing risk of complications from blood sampling for patient or investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility confirmation
Duration - Up to 33 months
Participants provide blood samples for gene panel testing and research purposes.
Up to 2 visits for blood sample collection
Duration - Up to 12 months
Participants are followed for up to 12 months to evaluate genomic profiling outcomes and feedback results to treating teams and patients.
Visits as needed for follow-up and data collection
Trial Site Locations
Total: 6 locations
1
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M20 4BX
Actively Recruiting
2
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
Actively Recruiting
3
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
Actively Recruiting
4
Northern Care Alliance NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
5
University Hospitals of Morecambe Bay NHS Trust
Morecambe, United Kingdom
Actively Recruiting
6
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom
Actively Recruiting
Research Team
E
EGG CUP Study Team
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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