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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-21

Study Completion Date

2018-04-30

Brief Summary

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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

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Conditions

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Neuroendocrine Tumors

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Data collection

Intervention Type OTHER

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.

Data collection

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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A-ES-52030-367

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Group A - Uncontrolled CS

Data collection

Group B - Controlled CS

Data collection

Interventions

Data collection

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Ipsen

Responsible Party

Principal Investigators

Ipsen Medical Director

Locations

Hospital General Univ. de Elche

ICO Badalona

Hospital Clínico y Provincial de Barcelona

Hospital de Bellvitge

Hospital Puerta del Mar

Hospital General Univ. de Ciudad Real

Hospital Univ. Donostia

Hospital Univ. de Guadalajara

Hospital Univ. Severo Ochoa

Hospital Univ. La Princesa

Hospital Univ. Ramón y Cajal

Hospital Clínico de San Carlos

Hospital 12 de Octubre

Hospital Univ. la Paz

Hospital Gregorio Marañón

Hospital Virgen de la Victoria

Hospital Morales Meseguer

Hospital Univ. Central de Asturias

Hospital Univ. Son Espases

Hospital Montecelo

Hospital Clín. Univ. de Salamanca

Hospital Virgen del Rocío

Hospital Virgen de la Salud

Hospital Doctor Peset

Hospital la Fe de Valencia

Hospital do Meixoeiro

Hospital Clínico Univ. Lozano Blesa

Hospital Univ. Miguel Servet

Countries

Other Identifiers

A-ES-52030-367