An observational study in Pancreatic Neuroendocrine Tumor, sponsored by Ipsen. Terminated at 46 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-14.
Sponsored by Ipsen · Observational
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.
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's enrollment of 54 is below the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hospital patients
Exclusion Criteria:
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.
Time frame: 24 months
Progression-free survival (PFS) rate at 12 months
PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment
Time frame: 12 months
Medical tumour-related intervention
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
Time frame: Baseline
Time from diagnosis to first therapeutic intervention
Description of the disease history management of subjects with PanNET
Time frame: 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".
Time frame: From baseline up to 24 months
Median time to lanreotide discontinuation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: Baseline visit and 12 months
This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Ipsen