Neuroendocrine Tumors
Conditions
Brief 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
OTHERData collection
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).
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Change from Baseline to Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline to Month 3 and Month 6 on dimensions of the QLQ-INFO25 self-administered questionnaire not part of the primary endpoint | 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 | Change from Baseline to Month 3 and 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 | Change from Baseline to Month 3 |
| Changes of biochemical markers expressed in terms of results (decrease, stable, increase) as part of the monitoring of the NET | 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 | Month 3 and Month 6 |
| Changes of symptoms assessments (presence of symptoms or not) as part of the monitoring of the Neuroendocrine Tumor (NET) | Change from Baseline to Month 3 and to Month 6 |
Countries
France
Outcome results
None listed