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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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ClinicalTrials.gov Identifier: NCT03220087
Recruitment Status : Completed
First Posted : July 18, 2017
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Other: Data collection

Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : July 21, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018


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.




Primary Outcome Measures :
  1. Use of resources and costs in patients with controlled or uncontrolled CS [ Time Frame: 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 :
  1. Clinical characteristics and therapeutic management of patients with NET and controlled or uncontrolled CS [ Time Frame: 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.

  2. Relationship between the state of health perceived by the patient and the clinical status of the disease reported by the physician. [ Time Frame: 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220087


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

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03220087     History of Changes
Other Study ID Numbers: A-ES-52030-367
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders