Status
Completed
Phase
Not applicable
Enrollment
115
Locations
1
Results
Not posted
Publications
0
Study summary
The purpose of the study is to evaluate, in standard practice, the change in information received and perceived by the patient, extension of the disease and its treatment. These parameters will be evaluated by means of validated self-administered questionnaires that can be used in standard practice.
Interventions
OTHER
The study is an observational evaluation that does not affect physician practices, the physician-patient relationship, or the care of subjects. The prescriptions will be decided prior to inclusion of the subject into the study. The information will be recorded using the data available in the medical file or collected during the visit (as part of the routine subject management).
Timeline
First posted
Jun 19, 2018
Study start
Jul 20, 2018
Primary completion
May 15, 2020
Study completion
May 15, 2020
Results posted
Not reported
Registry updated
Aug 28, 2020
Outcomes
Absolute variation on the score (standardized on a scale from 0 to 100) of the 3 targeted dimensions (disease, treatments and supportive care) of the self-administered Quality of Life Questionnaire (QLQ) QLQINFO25
Time frame · Change from Baseline to Month 6
Change from baseline to Month 3 of the 3 targeted dimensions (disease, treatments and supportive care (ie, other services)) of QLQ-INFO25 self-administered questionnaire
Time frame · Change from Baseline to Month 3
Changes from baseline to Month 3 and Month 6 on dimensions of the QLQ-INFO25 self-administered questionnaire not part of the primary endpoint
Time frame · Change from Baseline to Month 3 and 6
Change from baseline to Month 3 and Month 6 in quality of life using QLQ-C30 questionnaire
Time frame · Change from Baseline to Month 3 and Month 6
Changes of symptoms assessments (presence of symptoms or not) as part of the monitoring of the Neuroendocrine Tumor (NET)
Time frame · Change from Baseline to Month 3 and to Month 6
Changes of biochemical markers expressed in terms of results (decrease, stable, increase) as part of the monitoring of the NET
Time frame · Change from Baseline to Month 3 and to Month 6
Progression (yes/no) of NET on imaging as part of the monitoring of the NET
Time frame · Month 3 and Month 6
Eligibility
Inclusion Criteria: * Gastroenteropancreatic neuroendocrine tumor (GEPNET), histologically proven, grade 1 or 2, * Subject eligible for antitumor treatment initiation with lanreotide autogel\*, alone or combined with other therapies, selected freely and prior to inclusion in the study by the physician, * Subject able to complete a self-administered evaluation questionnaire during initiation visit and liable to be seen again within 6 months of the initial visit based on the physician's usual practices * Having consented in writing to his/her data being accessed for participation in the study. Exclusion Criteria: * Previously treated by lanreotide autogel * Simultaneously participating in a clinical trial
Study locations
France. Showing up to 24 locations stored in the fast local snapshot.
Ipsen Central Contact
Paris, France
Publications
No PMID-linked publications were present in this registry snapshot.
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