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Brief Title: Circulating Tumour Cells in Somatuline Autogel Treated NeuroEndocrine Tumours Patients
Official Title: A Phase IV, Multicentre, Open Label, Single Group Exploratory Study to Assess the Clinical Value of Enumeration of Circulating Tumour Cells (CTCs) to Predict Clinical Symptomatic Response and Progression Free Survival in Patients Receiving Deep Subcutaneous Administrations of Somatuline® (Lanreotide) Autogel® to Treat the Symptoms of Functioning Midgut NeuroEndocrine Tumours (NET)
Study ID: NCT02075606
Brief Summary: Circulating tumour cells (CTCs) are detectable in the blood in around 50% of patients with functioning NeuroEndocrine Tumours (NET) arising in the midgut area (tumours which are secreting hormones and are located in the area in the middle of the digestive system) and their presence usually means that the prognosis for the patient is poor. CTCs have also been shown to be valuable as predictive markers following treatment and there is increasing interest in using CTCs as 'liquid biopsies' that can help to inform treatment decisions. CTC analysis has the benefit of being relatively non- invasive and quick compared with a conventional CT scan and is therefore an attractive method of monitoring the tumour throughout the treatment period. The purpose of this study is to assess the clinical value that enumeration will have in predicting the clinical symptomatic response and progression free survival in patients receiving Somatuline Autogel for functioning midgut NETs over a one year period.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Basingstoke & North Hampshire Hospital, Basingstoke, , United Kingdom
Queen Elizabeth Hospital, Birmingham, , United Kingdom
University Hospital Wales, Cardiff, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
St James's University Hospital, Leeds, , United Kingdom
University Hospital Aintree, Liverpool, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
King's College Hospital, London, , United Kingdom
Royal Free Hospital, London, , United Kingdom
Maidstone Hospital, Maidstone, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
Norfolk & Norwich Hospital, Norwich, , United Kingdom
Royal Hallamshire Hospital, Sheffield, , United Kingdom
Southampton University Hospital, Southampton, , United Kingdom
Name: Matthew Hickling, MD
Affiliation: Ipsen
Role: STUDY_DIRECTOR