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| ID | Type | Description | Link |
|---|---|---|---|
| IPS-LAN-2018-01 | Other Identifier | Spanish Drug Agency AEMPS |
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Low enrollment
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The purpose of the protocol is to estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment, at 24 months after treatment initiation with lanreotide 120 mg every 28 days.
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) rate at 24 months | To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) rate at 12 months | PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment | 12 months |
| Medical tumour-related intervention |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| IPO Coimbra | Coimbra | 300-075 | Portugal | |||
| IPO Lisboa |
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Description of the disease history management of subjects with PanNET will be collected by the investigator and recorded in an electronic CRF (eCRF) designed for the study
| Baseline |
| Time from diagnosis to first therapeutic intervention | Description of the disease history management of subjects with PanNET | Baseline |
| Quality of Life (QoL) | To describe the change in Quality of Life (QoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire for gastrointestinal neuroendocrine tumours (QLQ-GINET21) questionnaires.Where the patient assess experienced symptoms or problems using the scale from 1 to 4. Where 1 represents "not at all" and 4 "very much". | From baseline up to 24 months |
| Median time to lanreotide discontinuation | Up to 24 months |
| Changes of Chromogranin A (CgA) levels | Changes in CgA levels between last CgA value prior to lanreotide start (if available) and values at each study visit | Every 6 months up to 24 months |
| Changes of Glycated hemoglobin (HbA1c) levels | Changes in HbA1c levels between last HbA1c value prior to lanreotide start (if available) and values at each study visit | Every 6 months up to 24 months |
| Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels | Changes in 5-HIAA levels between last 5-HIAA value prior to lanreotide start (if available) and values at each study visit | Every 6 months up to 24 months |
| Changes of pro-Brain Natriuretic Peptide (proBNP) levels | Changes in proBNP levels between last proBNP value prior to lanreotide start (if available) and values at each study visit | Every 6 months up to 24 months |
| Patient satisfaction | To evaluate patient' satisfaction (TSQM-9 questionnaire) at inclusion visit. Treatment Satisfaction Questionnaire for Medication (TSQM) is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. The effectiveness scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the convenience scored as 1(extremely difficult) to 7 (extremely easy). | Baseline visit and 12 months |
| Lisbon |
| 1099-023 |
| Portugal |
| Hospital São João | Porto | 4200-319 | Portugal |
| Hospital General de Alicante | Alicante | 03010 | Spain |
| Hospital Torrecardenas | Almería | 04009 | Spain |
| Hospital Universitario de Badajoz | Badajoz | 06010 | Spain |
| ICO Badalona | Badalona | 08916 | Spain |
| Hospital de Cruces | Barakaldo | 48903 | Spain |
| Hospital Universitario Vall Hebrón | Barcelona | 08035 | Spain |
| Hospital Santa Creu I Sant Pau | Barcelona | Spain |
| Hospital Basurto | Bilbao | 48013 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital Universitario Puerto Real | Cadiz | 11510 | Spain |
| Hospital San Pedro de Alcántara | Cáceres | 10003 | Spain |
| Hospital General Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hospital Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Juan Ramón Jimenez | Huelva | 21005 | Spain |
| Hospital Can Misses | Ibiza Town | 07800 | Spain |
| Hospital de Jerez | Jerez de la Frontera | 11407 | Spain |
| ICO Bellvitge | L'Hospitalet de Llobregat | 08908 | Spain |
| Hospital U. de Gran Canaria Negrín | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital Virgen de La Victoria | Málaga | 29010 | Spain |
| Hospital Clínico U. Virgen de la Arrixaca | Murcia | 30120 | Spain |
| Hospital Morales Meseguer | Murcia | Spain |
| Hospital Santa María Nai | Ourense | 32005 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Son Espases | Palma de Mallorca | 07120 | Spain |
| Hospital de Navarra | Pamplona | 31008 | Spain |
| Hospital Sant Joan de Reus | Reus | 43204 | Spain |
| Corporació Sanitària Parc Taulí | Sabadell | Spain |
| Hospital Clínico de Salamanca | Salamanca | 37007 | Spain |
| Hospital U. Nuestra Señora de Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Hospital Marqués de Valdecillas | Santander | 39008 | Spain |
| Hospital Conxo | Santiago de Compostela | 15706 | Spain |
| Hospital General de Segovia | Segovia | 40002 | Spain |
| Hospital Virgen Macarena | Seville | 41009 | Spain |
| Hs. Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Mutua Terrassa | Terrassa | 08221 | Spain |
| Hospital Virgen de la Salud Toledo | Toledo | 45004 | Spain |
| Hospital General de Valencia | Valencia | 46014 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46014 | Spain |
| Hospital Álvaro Cunqueiro | Vigo | 36312 | Spain |
| Hospital Lozano Blesa | Zaragoza | 50009 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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