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A Phase IV (post marketing), multicentre, open label, single group study to look at the clinical value of counting Circulating Tumour Cells in order to predict the clinical response in patients receiv...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-002194-22

A Phase IV (post marketing), multicentre, open label, single group study to look at the clinical value of counting Circulating Tumour Cells in order to predict the clinical response in patients receiving deep injections of Somatuline Autogel into the fat layer of the skin to treat the symptoms of functioning Neuroendocrine Tumours (tumours which secrete hormones) which are located in the intestines

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Extrait

The principal objective in the study is to assess whether counting the number of circulating tumour cells (CTCs) in the bloodstream of patients with functioning neuroendocrine tumours (NETs) (tumours which release hormones) in the midgut region is an effective tool to predict how the symptoms patients suffer from will respond when they are taking Somatuline Autogel. This process will be of considerable benefit to patients if it is shown to be effective as it will, in effect, be a ‘liquid biopsy’ procedure which is minimally invasive and relatively quick. It will help to optimise treatment decisions for patients in the future. The primary exploratory objective is to see whether counting the number of circulating tumour cells (CTCs)in the bloodstream of patients with funtioning neuroendocrine tumours (NETs)in the midgut region is able to predict how long these patients will survive before their disease progresses.

Critère d'inclusion

  • Symptoms of Neuro Endocrine tumours

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