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

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Ipsen

Status

Completed

Conditions

Neuroendocrine Tumors

Treatments

Other: Data collection

Study type

Observational

Funder types

Industry

Identifiers

NCT03220087
A-ES-52030-367

Details and patient eligibility

About

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.

Enrollment

142 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

142 participants in 2 patient groups

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

Trial contacts and locations

28

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Data sourced from clinicaltrials.gov

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