Neuroendocrine TumorsRECOSYNCT03220087
Study to Evaluate the Use of Resources and the Costs Associated With Carcinoid Syndrome (CS) in Patients With NETs in Spain
An observational study of Neuroendocrine Tumors, run by Ipsen at 28 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Data collection
- How many people
- 142 participants
- Where
- 28 sitesSpain
- Study dates
- 21 Jul 2017to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital patients
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
28 sites in 1 country.
28 sites in 1 country
Spain28 sites
Hospital General Univ. de Elche
Alicante, 03203
ICO Badalona
Badalona, 08916
Hospital Clínico y Provincial de Barcelona
Barcelona, 08036
Hospital de Bellvitge
Barcelona, 08907
Hospital Puerta del Mar
Cadiz, 11009
Hospital General Univ. de Ciudad Real
Ciudad Real, 13005
Hospital Univ. Donostia
Donostia / San Sebastian, 20014
Hospital Univ. de Guadalajara
Guadalajara, 19001
Hospital Univ. Severo Ochoa
Leganés, 28911
Hospital Univ. La Princesa
Madrid, 28006
Hospital Univ. Ramón y Cajal
Madrid, 28034
Hospital Clínico de San Carlos
Madrid, 28040
Hospital 12 de Octubre
Madrid, 28041
Hospital Univ. la Paz
Madrid, 28046
Hospital Gregorio Marañón
Madrid, 28807
Hospital Virgen de la Victoria
Málaga, 29010
Hospital Morales Meseguer
Murcia, 30008
Hospital Univ. Central de Asturias
Oviedo, 33011
Hospital Univ. Son Espases
Palma de Mallorca, 07120
Hospital Montecelo
Pontevedra, 36071
Hospital Clín. Univ. de Salamanca
Salamanca, 37007
Hospital Virgen del Rocío
Seville, 41013
Hospital Virgen de la Salud
Toledo, 45004
Hospital Doctor Peset
Valencia, 46017
Hospital la Fe de Valencia
Valencia, 46026
Hospital do Meixoeiro
Vigo, 36214
Hospital Clínico Univ. Lozano Blesa
Zaragoza, 50009
Hospital Univ. Miguel Servet
Zaragoza, 50009
About this study
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
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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Data collection
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection | |
| Group B - Controlled CS | Patients who have not had any episode of uncontrolled CS, according to medical criteria, in the last 12 months. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of resources and costs in patients with controlled or uncontrolled CS
Measured: 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
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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start21 Jul 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220087
- Sponsor's protocol ID
- A-ES-52030-367
- Acronym
- RECOSY
- Status last verified
- Dec 2018
- First submitted
- 26 Jun 2017
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03220087
- Acronym / sponsor ID
- RECOSY / A-ES-52030-367
- Conditions
- Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Uncontrolled CS | – | Other: Data collectionPatients 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 | – | Other: Data collectionPatients who have not had any episode of uncontrolled CS, according to medical criteria, in the last 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patients
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionThe 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. | Other | Group A - Uncontrolled CS, Group B - Controlled CS |
Primary outcome
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)
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Ipsen at 28 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.