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

Completed

• Conditions: Neuroendocrine Tumors
• Interventions: Other: Data collection

• Registration Number: NCT03220087
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-18
• Study Start: 2017-07-21
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)	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.

Trial Locations

Locations (28)

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 Univ. Donostia; 🇪🇸 Donostia, Spain

Hospital General Univ. de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Univ. de Guadalajara; 🇪🇸 Guadalajara, Spain

Hospital Univ. Severo Ochoa; 🇪🇸 Leganés, Spain

Hospital Univ. Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Univ. La Princesa; 🇪🇸 Madrid, Spain

Hospital Clínico de San Carlos; 🇪🇸 Madrid, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Univ. la Paz; 🇪🇸 Madrid, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Morales Meseguer; 🇪🇸 Murcia, Spain

Hospital Montecelo; 🇪🇸 Pontevedra, Spain

Hospital Univ. Central de Asturias; 🇪🇸 Oviedo, Spain

Hospital Univ. Son Espases; 🇪🇸 Palma De Mallorca, Spain

Hospital Clín. Univ. de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital la Fe de Valencia; 🇪🇸 Valencia, Spain

Hospital Doctor Peset; 🇪🇸 Valencia, Spain

Hospital do Meixoeiro; 🇪🇸 Vigo, Spain

Hospital Clínico Univ. Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Univ. Miguel Servet; 🇪🇸 Zaragoza, Spain