Enabling Genomic Testing in Cancer of Unknown Primary

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-15

Study Completion Date

2027-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer of Unknown Primary Neoplasm, Unknown Primary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

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

Gene panel array

Intervention Type DIAGNOSTIC_TEST

Blood sample collection for gene panel testing

Blood Sample Collection

Intervention Type OTHER

Blood sample collection for research purposes

Interventions

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Gene panel array

Blood sample collection for gene panel testing

Intervention Type DIAGNOSTIC_TEST

Blood Sample Collection

Blood sample collection for research purposes

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No