Circulating Tumour Cells in Somatuline Autogel treated NET patients
Research type
Research Study
Full 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).
IRAS ID
135995
Contact name
Tim Meyer
Contact email
Sponsor organisation
Ipsen Limited
Eudract number
2013-002194-22
Research summary
Neuroendocrine tumours (NETs) are a rare group of tumours which have the potential to become malignant (cancerous). About three cases per 100,000 patients per year are seen, with slightly more women than men being affected. The progression of the tumours is variable, with survival ranging from approximately 6 months in aggressive tumours to up to 20 years in slower growing tumours.
In recent years, many new anti-cancer agents have been developed. While these new agents have led to an improvement in response rate and life expectancy, they have also highlighted the need for tools to select patients who would benefit most from these therapies. Once patients develop metastatic disease (tumours spreading to other parts of the body), treatment is tailored to improving quality of life and prolonging life expectancy. Balancing the side-effects that are inevitably associated with cancer treatment against treatment benefits means that there is a need to ensure treatment is only given to those who are likely to respond to a drug.
Circulating tumour cells (CTCs) are detectable in the blood in around 50% of patients with functioning NET tumours 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.
REC name
London - City & East Research Ethics Committee
REC reference
13/LO/1557
Date of REC Opinion
14 Jan 2014
REC opinion
Further Information Favourable Opinion