Gastrointestinal Neuroendocrine Tumours Clinical Trial
— QUALINETSOfficial 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
| Verified date | November 2020 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical and therapeutic decisions.
| Status | Completed |
| Enrollment | 199 |
| Est. completion date | January 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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). |
| Country | Name | City | State |
|---|---|---|---|
| Portugal | Instituto Portuguès de Oncologia de Lisboa | Lisboa | |
| Portugal | Instituto Portuguès de Oncologia do Porto | Porto | |
| Spain | Hospital General Univ. Elche | Alicante | |
| Spain | Hospital Clinico y Provincial | Barcelona | |
| Spain | Hospital Univ. Burgos | Burgos | |
| Spain | Hospital San Pedro de Alcántara | Cáceres | |
| Spain | Hospital Jerez de la Frontera | Cádiz | |
| Spain | Hospital General Univ. Ciudad Real | Ciudad Real | |
| Spain | Hospital Univ. de Cabueñes | Gijón | |
| Spain | ICO Girona | Girona | |
| Spain | Hospital Can Mises | Ibiza | |
| Spain | Hospital Univ. León | León | |
| Spain | Hospital Clínico San Carlos | Madrid | |
| Spain | Hospital de La Princesa | Madrid | |
| Spain | Hospital Gregorio Marañón | Madrid | |
| Spain | Hospital Univ. Puerta del Hierro | Madrid | |
| Spain | Hospital Univ. Ramón y Cajal | Madrid | |
| Spain | Hospital Univ.Virgen de la Victoria | Malaga | |
| Spain | Hospital Regional Univ. Málaga | Málaga | |
| Spain | Hospital Rey Juan Carlos I | Móstoles | |
| Spain | Hospital General Univ. Morales Meseguer | Murcia | |
| Spain | Hospital Son Llàtzer | Palma | |
| Spain | Hospital Univ. Son Espases | Palma | |
| Spain | Complejo Hospitalario de Navarra | Pamplona | |
| Spain | Hospital Clínico Univ. Salamanca | Salamanca | |
| Spain | Hospital Clínico Univ. de Santiago | Santiago de Compostela | |
| Spain | Hospital General de Segovia | Segovia | |
| Spain | Hospital Univ. Virgen del Rocío | Sevilla | |
| Spain | Hospital Univ. Mútua de Terrasa | Terrassa | |
| Spain | Hospital de Galdakao | Usansolo | |
| Spain | Hospital Univ. Fe | Valencia | |
| Spain | Hospital Clínico Univ. Valladolid | Valladolid |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
Portugal, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survey on the clinical utility of the QLQ-GINET21, which the investigator is to complete for each patient enrolled | Day 1 | ||
| Secondary | 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 | Day 1 | |
| Secondary | Socio-demographic variables of the patient | Descriptive analysis of socio-demographic variables including age, gender, employment status, marital status, educational level | Day 1 | |
| Secondary | Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-GINET21 | Day 1 | ||
| Secondary | Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-C30 | Day 1 | ||
| Secondary | Clinical characteristics of patients - time since first therapeutic intervention | Day 1 | ||
| Secondary | 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. | Day 1 | |
| Secondary | 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. | Day 1 |