Clinical trial NCT03562091: Perception of Information and Quality of Life in Neuroendocrine Tumour on Lanreotide Autogel
Official title: Observational Study on Perception of Information and Quality of Life in Neuroendocrine Tumor on Lanreotide Autogel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-06-19
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with Gastroenteropancreatic neuroendocrine tumor (GEPNET) from Primary care clinics

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Change from Baseline to Month 6
Secondary outcomes:
measure: 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
timeFrame: Change from Baseline to Month 3
measure: Changes from baseline to Month 3 and Month 6 on dimensions of the QLQ-INFO25 self-administered questionnaire not part of the primary endpoint
timeFrame: Change from Baseline to Month 3 and 6
measure: Change from baseline to Month 3 and Month 6 in quality of life using QLQ-C30 questionnaire
timeFrame: Change from Baseline to Month 3 and Month 6
measure: Changes of symptoms assessments (presence of symptoms or not) as part of the monitoring of the Neuroendocrine Tumor (NET)
timeFrame: Change from Baseline to Month 3 and to Month 6
measure: Changes of biochemical markers expressed in terms of results (decrease, stable, increase) as part of the monitoring of the NET
timeFrame: Change from Baseline to Month 3 and to Month 6
measure: Progression (yes/no) of NET on imaging as part of the monitoring of the NET
timeFrame: Month 3 and Month 6
Other outcomes:
Locations:
city: Paris
country: France
facility: Ipsen Central Contact
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: