- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562091
Perception of Information and Quality of Life in Neuroendocrine Tumour on Lanreotide Autogel (OPERA)
August 27, 2020 updated by: Ipsen
Observational Study on Perception of Information and Quality of Life in Neuroendocrine Tumor on Lanreotide Autogel
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
115
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France
- Ipsen Central Contact
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects with Gastroenteropancreatic neuroendocrine tumor (GEPNET) from Primary care clinics
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: Change from Baseline to Month 6
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Change from Baseline to Month 6
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: Change from Baseline to Month 3
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Change from Baseline to Month 3
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Changes from baseline to Month 3 and Month 6 on dimensions of the QLQ-INFO25 self-administered questionnaire not part of the primary endpoint
Time Frame: Change from Baseline to Month 3 and 6
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Change from Baseline to Month 3 and 6
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Change from baseline to Month 3 and Month 6 in quality of life using QLQ-C30 questionnaire
Time Frame: Change from Baseline to Month 3 and Month 6
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Change from Baseline to Month 3 and Month 6
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Changes of symptoms assessments (presence of symptoms or not) as part of the monitoring of the Neuroendocrine Tumor (NET)
Time Frame: Change from Baseline to Month 3 and to Month 6
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Change from Baseline to Month 3 and to Month 6
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Changes of biochemical markers expressed in terms of results (decrease, stable, increase) as part of the monitoring of the NET
Time Frame: Change from Baseline to Month 3 and to Month 6
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Change from Baseline to Month 3 and to Month 6
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Progression (yes/no) of NET on imaging as part of the monitoring of the NET
Time Frame: Month 3 and Month 6
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Month 3 and Month 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2018
Primary Completion (Actual)
May 15, 2020
Study Completion (Actual)
May 15, 2020
Study Registration Dates
First Submitted
May 17, 2018
First Submitted That Met QC Criteria
June 8, 2018
First Posted (Actual)
June 19, 2018
Study Record Updates
Last Update Posted (Actual)
August 28, 2020
Last Update Submitted That Met QC Criteria
August 27, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-FR-52030-371
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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