Clinical trial NCT03220087: Study to Evaluate the Use of Resources and the Costs Associated With Carcinoid Syndrome (CS) in Patients With NETs in Spain
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2017-07-18
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patients

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.


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.

  1. Group A: patient who has had at least one episode of uncontrolled CS, according to medical criteria, since the start of treatment.
  2. 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.

Primary outcomes:
measure: Use of resources and costs in patients with controlled or uncontrolled CS
timeFrame: 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:
measure: Clinical characteristics and therapeutic management of patients with NET and controlled or uncontrolled CS
timeFrame: 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)
measure: Relationship between the state of health perceived by the patient and the clinical status of the disease reported by the physician.
timeFrame: 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)
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Univ. de Elche
city: Badalona
country: Spain
facility: ICO Badalona
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
city: Ciudad Real
country: Spain
facility: Hospital General Univ. de Ciudad Real
city: Donostia
country: Spain
facility: Hospital Univ. Donostia
city: Guadalajara
country: Spain
facility: Hospital Univ. de Guadalajara
city: Leganés
country: Spain
facility: Hospital Univ. Severo Ochoa
city: Madrid
country: Spain
facility: Hospital Univ. La Princesa
city: Madrid
country: Spain
facility: Hospital Univ. Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico de San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Univ. la Paz
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias
city: Palma De Mallorca
country: Spain
facility: Hospital Univ. Son Espases
city: Pontevedra
country: Spain
facility: Hospital Montecelo
city: Salamanca
country: Spain
facility: Hospital Clín. Univ. de Salamanca
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Valencia
country: Spain
facility: Hospital la Fe de Valencia
city: Vigo
country: Spain
facility: Hospital do Meixoeiro
city: Zaragoza
country: Spain
facility: Hospital Clínico Univ. Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Univ. Miguel Servet
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: