Study to Evaluate the Use of Resources and the Costs Associated With Carcinoid Syndrome (CS) in Patients With NETs in Spain
RECOSY
1 other identifier
observational
142
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2017
Shorter than P25 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedStudy Start
First participant enrolled
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedDecember 21, 2018
December 1, 2018
9 months
June 26, 2017
December 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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)
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)
Study Arms (2)
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.
Interventions
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.
Eligibility Criteria
Hospital patients
You may qualify if:
- 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.
- Group A: patient who has had at least one episode of uncontrolled CS, according to medical criteria, since the start of treatment.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (28)
Hospital General Univ. de Elche
Alicante, 03203, Spain
ICO Badalona
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2017
First Posted
July 18, 2017
Study Start
July 21, 2017
Primary Completion
April 30, 2018
Study Completion
April 30, 2018
Last Updated
December 21, 2018
Record last verified: 2018-12