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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03203
    • Hospital General Univ. De Elche
  • Badalona, Spain, 08916
    • Ico Badalona
  • Barcelona, Spain, 08036
    • Hospital Clínico y Provincial de Barcelona
  • Barcelona, Spain, 08907
    • Hospital De Bellvitge
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar
  • Ciudad Real, Spain, 13005
    • Hospital General Univ. de Ciudad Real
  • Donostia, Spain, 20014
    • Hospital Univ. Donostia
  • Guadalajara, Spain, 19001
    • Hospital Univ. de Guadalajara
  • Leganés, Spain, 28911
    • Hospital Univ. Severo Ochoa
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Univ. La Paz
  • Madrid, Spain, 28034
    • Hospital Univ. Ramón y Cajal
  • Madrid, Spain, 28006
    • Hospital Univ. La Princesa
  • Madrid, Spain, 28040
    • Hospital Clinico de San Carlos
  • Madrid, Spain, 28807
    • Hospital Gregorio Marañon
  • Murcia, Spain, 30008
    • Hospital Morales Meseguer
  • Málaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Oviedo, Spain, 33011
    • Hospital Univ. Central de Asturias
  • Palma De Mallorca, Spain, 07120
    • Hospital Univ. Son Espases
  • Pontevedra, Spain, 36071
    • Hospital Montecelo
  • Salamanca, Spain, 37007
    • Hospital Clín. Univ. de Salamanca
  • Sevilla, Spain, 41013
    • Hospital Virgen Del Rocio
  • Toledo, Spain, 45004
    • Hospital Virgen de la Salud
  • Valencia, Spain, 46017
    • Hospital Doctor Peset
  • Valencia, Spain, 46026
    • Hospital La Fe de Valencia
  • Vigo, Spain, 36214
    • Hospital Do Meixoeiro
  • Zaragoza, Spain, 50009
    • Hospital Clinico Univ. Lozano Blesa
  • Zaragoza, Spain, 50009
    • Hospital Univ. Miguel Servet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A - Uncontrolled CS; Patients who have had at least one episode of uncontrolled CS, according to medical criteria, since the start of their treatment for NET.	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.
Group B - Controlled CS; Patients who have not had any episode of uncontrolled CS, according to medical criteria, in the last 12 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Drug-Related Side Effects and Adverse Reactions; Neuroendocrine Tumors; Carcinoid Tumor; Malignant Carcinoid Syndrome; Serotonin Syndrome
• Other Study ID Numbers: A-ES-52030-367