Enabling genomic testing in cancer of unknown primary

Not Applicable

Conditions: Cancer of unknown primary
Cancer

Registration Number: ISRCTN42910771

Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Aged 16 years or over
2. Written informed consent according to Good Clinical Practice (GCP) and national regulations
3. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
4. Confirmed diagnosis of CUP as per the European Society for Medical Oncology (ESMO) guidelines. Patients must have:
4.1. The local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis
4.2. 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 the risk of complications for the patients and/or investigator

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The utility of cfDNA molecular profiling in patients diagnosed with CUP as determined by:<br>1. Percentage of patients with adequate cfDNA yields measured using FoundationOne®? Liquid CDx testing of blood samples obtained at baseline or progression timepoints<br>2. Percentage of patients with actionable genomic alterations measured using FoundationOne®? Liquid CDx testing of blood samples obtained at baseline or progression timepoints<br>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

Secondary Outcome Measures

Name	Time	Method
1. 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<br>2. Routinely incorporate molecular genomics as standard of care in patients diagnosed with CUP (working with the NHS England Genomic Medicine Service) following FoundationOne®? CDx or FoundationOne®? Liquid CDx at baseline and FoundationOne®? Liquid CDx at progression<br>3. 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

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