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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Group B - Controlled CS | Patients who have not had any episode of uncontrolled CS, according to medical criteria, in the last 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | 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. |
| Measure | Description | 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) |
| 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. |
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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.
Patient able to read and understand the study questionnaires.
Patient who has given written informed consent to participate in the study.
Exclusion Criteria:
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Hospital patients
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Univ. de Elche | Alicante | 03203 | Spain | |||
| ICO Badalona |
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|
| 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) |
| Badalona |
| 08916 |
| Spain |
| Hospital Clínico y Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital General Univ. de Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Univ. Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hospital Univ. de Guadalajara | Guadalajara | 19001 | Spain |
| Hospital Univ. Severo Ochoa | Leganés | 28911 | Spain |
| Hospital Univ. La Princesa | Madrid | 28006 | Spain |
| Hospital Univ. Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clínico de San Carlos | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Univ. la Paz | Madrid | 28046 | Spain |
| Hospital Gregorio Marañón | Madrid | 28807 | Spain |
| Hospital Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Morales Meseguer | Murcia | 30008 | Spain |
| Hospital Univ. Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Univ. Son Espases | Palma de Mallorca | 07120 | Spain |
| Hospital Montecelo | Pontevedra | 36071 | Spain |
| Hospital Clín. Univ. de Salamanca | Salamanca | 37007 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Virgen de la Salud | Toledo | 45004 | Spain |
| Hospital Doctor Peset | Valencia | 46017 | Spain |
| Hospital la Fe de Valencia | Valencia | 46026 | Spain |
| Hospital do Meixoeiro | Vigo | 36214 | Spain |
| Hospital Clínico Univ. Lozano Blesa | Zaragoza | 50009 | Spain |
| Hospital Univ. Miguel Servet | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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