Circulating Tumour Cells in Somatuline Autogel Treated NeuroEndocrine Tumours Patients
Condition: NeuroEndocrine Tumours
MeSH terms: Neuroendocrine Tumors; Neoplastic Cells, Circulating
Intervention: lanreotide acetate
Intervention description: Somatuline Autogel injection 120mg for first 3 months then 120, 90 or 60 mg administered via the deep subcutaneous route every 28 days
Intervention MeSH terms: Lanreotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NET; Symptomatic response; Functioning NeuroEndocrine Tumours; midgut region

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study related procedures.

          -  Patients (either sex) must be 18 years or older.

          -  Patients must be suffering from symptoms of diarrhoea and/or flushing at the time of
             study enrolment.

          -  Patients must have a documented diagnosis of a functioning midgut NET.

          -  In order to avoid patients with rapidly progressing tumours, only patients with well
             or moderately differentiated tumours and with a Ki67 proliferation index of <20% will
             be recruited.

          -  The clinically appropriate treatment for the patient must be therapy with a
             somatostatin analogue.

          -  Patients must have had either a positive somatostatin receptor scintigraphy result or
             a positive 68Gallium-DOTATATE PET imaging result.

        Exclusion Criteria:

          -  If the patient is at risk of pregnancy or is breast feeding, unless treatment with
             Somatuline Autogel is clearly needed (as determined by the clinician).

          -  The patient is, in the opinion of the investigator, unable to comply fully with the
             protocol and the study instructions, or present any concomitant condition which could
             compromise the objectives of the study and/or preclude the protocol-defined procedures
             (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or
             uncontrolled infection, known pituitary disease).

          -  The patient has been treated with any other unlicensed drug within the last 30 days
             before study entry or will require a concurrent treatment with any other experimental
             drugs or treatments.

          -  The patient has been treated with a somatostatin analogue prior to study entry, unless
             a washout period of at least 2 weeks for subcutaneous octreotide, or at least 6 weeks
             for a single dose of long acting somatostatin analogue has occurred.

          -  The patient has received interferon, chemotherapy, chemoembolisation or radionuclide
             therapy within 3 months prior to study entry.

          -  The patient has a history of hypersensitivity to drugs with a similar chemical
             structure.

          -  Females of childbearing potential must be using oral, double barrier or injectable
             contraception. Non childbearing potential is defined as being post-menopause for at
             least 1 year, surgical sterilisation or hysterectomy at least three months before the
             start of the study.

          -  The patient has abnormal baseline findings, any other medical condition(s) or
             laboratory findings that, in the opinion of the Investigator, might jeopardise the
             patient's safety or decrease the chance of obtaining satisfactory data needed to
             achieve the objective(s) of the study.