Study to Evaluate the Use of Resources and the Costs Associated With Controlled or Uncontrolled Carcinoid Syndrome in Patients With Neuroendocrine Tumours (NETs) in Spain

Ipsen28 sites in 1 country142 target enrollmentJuly 21, 2017

ConditionsNeuroendocrine Tumors

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neuroendocrine Tumors
Sponsor: Ipsen
Enrollment: 142
Locations: 28
Primary Endpoint: Use of resources and costs in patients with controlled or uncontrolled CS
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to describe the use of resources and the costs associated with controlled or uncontrolled CS in patients with NETs in Spain.

Registry

clinicaltrials.gov

Start Date

July 21, 2017

End Date

April 30, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient 18 years of age or older.
•Patient with a diagnosis of NET (G1 or G2) treated with Somatostatin Analogues (SSAs) to manage their symptoms.
•Group A: patient who has had at least one episode of uncontrolled CS, according to medical criteria, since the start of treatment.
•Group B: patient who has not had any episode of uncontrolled CS, according to medical criteria, in the last 12 months.
•Patient able to read and understand the study questionnaires.
•Patient who has given written informed consent to participate in the study.

Exclusion Criteria

•Patient participating in another clinical study when invited to participate in this study.
•Patient with another severe malignant disease.
•Patient who cannot meet the requirements established in the protocol (non-compliant or unfit to fill in the questionnaires).
•Patient with symptoms or diseases that could be confused with CS or render CS more difficult to evaluate: right cardiomyopathy or diarrhoea of any aetiology other than NET.

Outcomes

Primary Outcomes

Use of resources and costs in patients with controlled or uncontrolled CS

Time Frame: Day 1 (Group A retrospective data collection - 3 months before and up to 6/12 months after the last uncontrolled carcinoid episode. Group B retrospective data collection - up to 6/12 months before the date of enrolment)

Secondary Outcomes

Relationship between the state of health perceived by the patient and the clinical status of the disease reported by the physician.(Day 1 (Group A retrospective data collection - 3 months before and up to 6/12 months after the last uncontrolled carcinoid episode. Group B retrospective data collection - up to 6/12 months before the date of enrolment))
Clinical characteristics and therapeutic management of patients with NET and controlled or uncontrolled CS(Day 1 (Group A retrospective data collection - 3 months before and up to 6/12 months after the last uncontrolled carcinoid episode. Group B retrospective data collection - up to 6/12 months before the date of enrolment))