- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03947762
Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice. (PanNET)
June 9, 2021 updated by: Ipsen
Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
54
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Coimbra, Portugal, 300-075
- IPO Coimbra
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Lisboa, Portugal, 1099-023
- IPO Lisboa
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Porto, Portugal, 4200-319
- Hospital Sao Joao
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Alicante, Spain, 03010
- Hospital General de Alicante
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Almería, Spain, 04009
- Hospital Torrecárdenas
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Badajoz, Spain, 06010
- Hospital Universitario de Badajoz
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Badalona, Spain, 08916
- ICO Badalona
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Baracaldo, Spain, 48903
- Hospital De Cruces
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Barcelona, Spain
- Hospital Santa Creu i Sant Pau
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Barcelona, Spain, 08035
- Hospital Universitario Vall Hebron
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Bilbao, Spain, 48013
- Hospital Basurto
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Burgos, Spain, 09006
- Hospital Universitario de Burgos
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Cadiz, Spain, 11510
- Hospital Universitario Puerto Real
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Ciudad Real, Spain, 13005
- Hospital General Ciudad Real
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Cáceres, Spain, 10003
- Hospital San Pedro de Alcántara
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Córdoba, Spain, 14004
- Hospital Universitario Reina Sofia
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Donostia, Spain, 20014
- Hospital Donostia
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Granada, Spain, 18014
- Hospital Virgen de las Nieves
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Hospitalet de Llobregat, Spain, 08908
- ICO Bellvitge
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Huelva, Spain, 21005
- Hospital Juan Ramón Jiménez
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Ibiza, Spain, 07800
- Hospital Can Misses
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Jerez De La Frontera, Spain, 11407
- Hospital de Jerez
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Las Palmas De Gran Canaria, Spain, 35010
- Hospital U. de Gran Canaria Negrín
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Murcia, Spain
- Hospital Morales Meseguer
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Murcia, Spain, 30120
- Hospital Clínico U. Virgen de la Arrixaca
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Málaga, Spain, 29010
- Hospital Virgen de la Victoria
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Ourense, Spain, 32005
- Hospital Santa Maria Nai
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Oviedo, Spain, 33011
- Hospital Universitario Central de Asturias
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Palma De Mallorca, Spain, 07120
- Hospital Son Espases
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Pamplona, Spain, 31008
- Hospital de Navarra
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Reus, Spain, 43204
- Hospital Sant Joan de Reus
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Sabadell, Spain
- Corporacio Sanitaria Parc Tauli
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Salamanca, Spain, 37007
- Hospital Clínico de Salamanca
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Santa Cruz De Tenerife, Spain, 38010
- Hospital U. Nuestra Señora de Candelaria
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Santander, Spain, 39008
- Hospital Marqués de Valdecillas
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Santiago De Compostela, Spain, 15706
- Hospital Conxo
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Segovia, Spain, 40002
- Hospital General de Segovia
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Sevilla, Spain, 41009
- Hospital Virgen Macarena
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Sevilla, Spain, 41013
- Hs. Virgen del Rocio
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Terrassa, Spain, 08221
- Hospital Mutua Terrassa
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Toledo, Spain, 45004
- Hospital Virgen de la Salud Toledo
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Valencia, Spain, 46014
- Hospital General de Valencia
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Valencia, Spain, 46014
- Hospital Universitario y Politécnico La Fe
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Vigo, Spain, 36312
- Hospital Alvaro Cunqueiro
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Zaragoza, Spain, 50009
- Hospital Miguel Servet
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Zaragoza, Spain, 50009
- Hospital Lozano Blesa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hospital patients
Description
Inclusion Criteria:
- Subjects aged ≥ 18
- Subjects diagnosed of functioning or non-functioning PanNET, G1/ G2 (Ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months
- Subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation
- Subject with Eastern Cooperative Oncology Group (ECOG) ≤2
Exclusion Criteria:
- Subject who is participating in an interventional study
- Pregnant or breast-feeding women
- Subject who has received any previous therapy for PanNET (such as octreotide LAR, Molecular Targeted Therapy (MTT), Peptide receptor radionuclide therapy (PRRT), chemotherapy, etc.) except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) rate at 24 months
Time Frame: 24 months
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To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) rate at 12 months
Time Frame: 12 months
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PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment
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12 months
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Medical tumour-related intervention
Time Frame: Baseline
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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
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Baseline
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Time from diagnosis to first therapeutic intervention
Time Frame: Baseline
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Description of the disease history management of subjects with PanNET
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Baseline
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Quality of Life (QoL)
Time Frame: From baseline up to 24 months
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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".
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From baseline up to 24 months
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Median time to lanreotide discontinuation
Time Frame: Up to 24 months
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Up to 24 months
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Changes of Chromogranin A (CgA) levels
Time Frame: Every 6 months up to 24 months
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Changes in CgA levels between last CgA value prior to lanreotide start (if available) and values at each study visit
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Every 6 months up to 24 months
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Changes of Glycated hemoglobin (HbA1c) levels
Time Frame: Every 6 months up to 24 months
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Changes in HbA1c levels between last HbA1c value prior to lanreotide start (if available) and values at each study visit
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Every 6 months up to 24 months
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Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels
Time Frame: Every 6 months up to 24 months
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Changes in 5-HIAA levels between last 5-HIAA value prior to lanreotide start (if available) and values at each study visit
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Every 6 months up to 24 months
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Changes of pro-Brain Natriuretic Peptide (proBNP) levels
Time Frame: Every 6 months up to 24 months
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Changes in proBNP levels between last proBNP value prior to lanreotide start (if available) and values at each study visit
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Every 6 months up to 24 months
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Patient satisfaction
Time Frame: Baseline visit and 12 months
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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).
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Baseline visit and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 3, 2019
Primary Completion (ACTUAL)
April 30, 2021
Study Completion (ACTUAL)
April 30, 2021
Study Registration Dates
First Submitted
May 10, 2019
First Submitted That Met QC Criteria
May 10, 2019
First Posted (ACTUAL)
May 13, 2019
Study Record Updates
Last Update Posted (ACTUAL)
June 14, 2021
Last Update Submitted That Met QC Criteria
June 9, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Pancreatic Diseases
- Adenoma
- Pancreatic Neoplasms
- Neuroendocrine Tumors
- Adenoma, Islet Cell
Other Study ID Numbers
- A-ES-52030-383
- IPS-LAN-2018-01 (OTHER: Spanish Drug Agency AEMPS)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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