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

Neuroendocrine Tumors Clinical Trial

— OPERA  

Official title:

Observational Study on Perception of Information and Quality of Life in Neuroendocrine Tumor on Lanreotide Autogel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562091
• Other study ID #: A-FR-52030-371
• Status: Completed
• Start date: July 20, 2018
• Est. completion date: May 15, 2020

Study information

• Verified date: August 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Other:
• Data 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).

Locations

Country	Name	City	State
France	Ipsen Central Contact	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Progression (yes/no) of NET on imaging as part of the monitoring of the NET		Month 3 and Month 6