Perception of Information and Quality of Life in Neuroendocrine Tumour on Lanreotide Autogel

Completed

• Conditions: Neuroendocrine Tumors

• Registration Number: NCT03562091
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-19
• Study Start: 2018-07-20
• Primary Completion: 2020-05-15
• Study Completion: 2020-05-15
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Progression (yes/no) of NET on imaging as part of the monitoring of the NET	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 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
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
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
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

Trial Locations

Locations (1)

Ipsen Central Contact; 🇫🇷 Paris, France