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

Sponsor

Ipsen (Industry)

Overall Status

Completed

CT.gov ID

NCT03562091

Collaborator

(none)

115

Enrollment

Location

21.8

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumors	Other: Data collection

Study Design

Study Type:

Observational

Actual Enrollment :

115 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 20, 2018

Actual Primary Completion Date :

May 15, 2020

Actual Study Completion Date :

May 15, 2020

Outcome Measures

Primary Outcome Measures

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

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]
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 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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ipsen Central Contact	Paris		France

Sponsors and Collaborators

Ipsen

Investigators

Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ipsen

ClinicalTrials.gov Identifier:

NCT03562091

Other Study ID Numbers:

A-FR-52030-371

First Posted:

Jun 19, 2018

Last Update Posted:

Aug 28, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neuroendocrine Tumors

Study Results

No Results Posted as of Aug 28, 2020