Gastrointestinal Neuroendocrine TumoursQUALINETSNCT02853422
Quality-Of-Life QLQ-GINET21 Questionnaire In The Treatment Of Patients With Gastrointestinal Neuroendocrine Tumours
An observational study of Gastrointestinal Neuroendocrine Tumours, run by Ipsen at 32 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical and therapeutic decisions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neuroendocrine Tumours
- How many people
- 199 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Apr 2016to Jan 2017
- 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 with a diagnosis of gastrointestinal endocrine tumour.
- Patient able to read and understand the study questionnaires.
- Patient who has given informed consent in writing to take part in the study.
Who cannot join
- Patient who is taking part in another clinical study during the study.
- Patients with another serious malignancy.
- Patients unable to meet the requirements of the protocol (non-compliant patients or those unfit to answer the questionnaires).
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
Spain30 sites
Hospital General Univ. Elche
Alicante, 03203
Hospital Clinico y Provincial
Barcelona, 08036
Hospital Univ. Burgos
Burgos, 09006
Hospital San Pedro de Alcántara
Cáceres, 10003
Hospital Jerez de la Frontera
Cadiz, 11407
Hospital General Univ. Ciudad Real
Ciudad Real, 13005
Hospital Univ. de Cabueñes
Gijón, 33394
ICO Girona
Girona, 17007
Hospital Can Mises
Ibiza Town, 07800
Hospital Univ. León
León, 24001
Hospital de La Princesa
Madrid, 28006
Hospital Gregorio Marañón
Madrid, 28007
Hospital Univ. Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Univ. Puerta del Hierro
Madrid, 28222
Hospital Regional Univ. Málaga
Málaga, 29010
Hospital Univ.Virgen de la Victoria
Málaga, 29010
Hospital Rey Juan Carlos I
Móstoles, 28933
Hospital General Univ. Morales Meseguer
Murcia, 30008
Hospital Univ. Son Espases
Palma, 07120
Hospital Son Llàtzer
Palma, 07198
Complejo Hospitalario de Navarra
Pamplona, 31008
Hospital Clínico Univ. Salamanca
Salamanca, 37007
Hospital Clínico Univ. de Santiago
Santiago de Compostela, 15706
Hospital General de Segovia
Segovia, 40002
Hospital Univ. Virgen del Rocío
Seville, 41013
Hospital Univ. Mútua de Terrasa
Terrassa, 08221
Hospital de Galdakao
Usansolo, 48960
Hospital Univ. Fe
Valencia, 46026
Hospital Clínico Univ. Valladolid
Valladolid, 47003
Portugal2 sites
Instituto Portuguès de Oncologia de Lisboa
Lisbon, 1099-023
Instituto Portuguès de Oncologia do Porto
Porto, 4200-072
About this study
Official title: A Study Evaluating The Clinical Utility Of The Health-Related Quality-Of-Life QLQ-GINET21 Questionnaire In The Treatment Of Patients With Gastrointestinal Neuroendocrine Tumours QUALINETS Study
The purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical and therapeutic decisions.
- Conditions
- Gastrointestinal Neuroendocrine Tumours
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey on the clinical utility of the QLQ-GINET21, which the investigator is to complete for each patient enrolled
Measured: Day 1
Secondary outcomes (7)
Socio-demographic variables of the investigator
Descriptive analysis of socio-demographic variables including age, gender, years of experience in treating neuroendocrine tumours (NETs), area of professional activity, capacity of the hospital
Measured: Day 1
Socio-demographic variables of the patient
Descriptive analysis of socio-demographic variables including age, gender, employment status, marital status, educational level
Measured: Day 1
Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-GINET21
Measured: Day 1
Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-C30
Measured: Day 1
Clinical characteristics of patients - time since first therapeutic intervention
Measured: Day 1
Health status as perceived by the patient
Patients assess their overall health status in relation to their gastrointestinal neuroendocrine tumour, with a question designed for this purpose: "Please answer the question by marking the response that best defines your current health status as related to your neuroendocrine disease". The response options are: Very good, quite good, somewhat good, neither good nor bad, somewhat bad, quite bad, very bad.
Measured: Day 1
Clinical assessment of patient's health status by the investigator
The investigator evaluates the patient's health status in relation to the gastrointestinal neuroendocrine tumour by answering the following question: Overall, how would you rate the patient's health status in relation to their gastrointestinal neuroendocrine tumour as of today? The response options are: Very good, quite good, somewhat good, neither good nor bad, somewhat bad, quite bad, very bad.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Neuroendocrine TumoursStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 199 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
- NCT02853422
- Sponsor's protocol ID
- A-ES-52030-351
- Other IDs
- IPS-ANT- 2015-01
- Acronym
- QUALINETS
- Status last verified
- Nov 2020
- First submitted
- 28 Apr 2016
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating The Clinical Utility Of The Health-Related Quality-Of-Life QLQ-GINET21 Questionnaire In The Treatment Of Patients With Gastrointestinal Neuroendocrine Tumours QUALINETS Study
- ClinicalTrials.gov ID
- NCT02853422
- Acronym / sponsor ID
- QUALINETS / A-ES-52030-351
- Conditions
- Gastrointestinal Neuroendocrine Tumours
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Aug 2016 (estimated)
- 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 purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical and therapeutic decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
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 (3 listed)
- Patient with a diagnosis of gastrointestinal endocrine tumour.
- Patient able to read and understand the study questionnaires.
- Patient who has given informed consent in writing to take part in the study.
Key exclusion criteria (3 listed)
- Patient who is taking part in another clinical study during the study.
- Patients with another serious malignancy.
- Patients unable to meet the requirements of the protocol (non-compliant patients or those unfit to answer the questionnaires).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survey on the clinical utility of the QLQ-GINET21, which the investigator is to complete for each patient enrolled
Time frame: Day 1
7 secondary outcomes
Socio-demographic variables of the investigator
Time frame: Day 1
Socio-demographic variables of the patient
Time frame: Day 1
Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-GINET21
Time frame: Day 1
Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-C30
Time frame: Day 1
Clinical characteristics of patients - time since first therapeutic intervention
Time frame: Day 1
Health status as perceived by the patient
Time frame: Day 1
Clinical assessment of patient's health status by the investigator
Time frame: Day 1
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 5 Nov 2020.
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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
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Neuroendocrine Tumours, run by Ipsen at 32 sites in 2 countries.
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 3 inclusion and 3 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain, Portugal. 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?
Survey on the clinical utility of the QLQ-GINET21, which the investigator is to complete for each patient enrolled (time frame: Day 1). 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 5 Nov 2020.