Study to Evaluate the Use of Resources and the Costs Associated With Carcinoid Syndrome (CS) in Patients With NETs in Spain

Neuroendocrine Tumors Clinical Trial

— RECOSY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03220087
• Other study ID #: A-ES-52030-367
• Status: Completed
• Start date: July 21, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: December 2018
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoid Tumor
• Malignant Carcinoid Syndrome
• Neuroendocrine Tumors
• Serotonin Syndrome

Intervention

Other:
• Data collection
The study consists of a single visit in which socio-demographic and clinical variables will be collected from the medical record or directly from the patient. In addition, the physician will provide information on the clinical status of the disease and the patient will fill in the questionnaire.

Locations

Country	Name	City	State
Spain	Hospital General Univ. de Elche	Alicante
Spain	ICO Badalona	Badalona
Spain	Hospital Clínico y Provincial de Barcelona	Barcelona
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital Puerta del Mar	Cadiz
Spain	Hospital General Univ. de Ciudad Real	Ciudad Real
Spain	Hospital Univ. Donostia	Donostia
Spain	Hospital Univ. de Guadalajara	Guadalajara
Spain	Hospital Univ. Severo Ochoa	Leganés
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico de San Carlos	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Univ. la Paz	Madrid
Spain	Hospital Univ. La Princesa	Madrid
Spain	Hospital Univ. Ramón y Cajal	Madrid
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Morales Meseguer	Murcia
Spain	Hospital Univ. Central de Asturias	Oviedo
Spain	Hospital Univ. Son Espases	Palma De Mallorca
Spain	Hospital Montecelo	Pontevedra
Spain	Hospital Clín. Univ. de Salamanca	Salamanca
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Doctor Peset	Valencia
Spain	Hospital la Fe de Valencia	Valencia
Spain	Hospital do Meixoeiro	Vigo
Spain	Hospital Clínico Univ. Lozano Blesa	Zaragoza
Spain	Hospital Univ. Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of resources and costs in patients with 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)
Secondary	Clinical characteristics and therapeutic management of patients with NET and controlled or uncontrolled CS	A descriptive analysis of the diagnostic process; time of evolution of the disease; treatment prescribed following the diagnosis of NET and reason for choice; time elapsed from the diagnosis of NET to the first therapeutic intervention; prior and current drug treatment for NET and CS (active substance, type of treatment [rapid action vs prolonged action], dose and duration); concomitant diseases (including cardiac complications); New York Heart Association (NYHA) functional classification (I-IV); proBNP, chromogranin A and 5HIAA value; and value of the last echocardiogram, as well as any other treatments and interventions that the patient may have undergone (Yes/No, active substance and type of intervention) will be performed. The results will be compared between the two groups of patients using the paired t test for continuous variables and the Cochran-Mantel-Haenszel test or conditional logistic regression for categorical variables.	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	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)