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

• ClinicalTrials.gov Identifier: NCT03562091
• Recruitment Status: Recruiting
• First Posted: June 19, 2018
• Last Update Posted: September 30, 2019
• Sponsor: Ipsen
• Information provided by (Responsible Party): Ipsen

Tracking Information

• First Submitted Date: May 17, 2018
• First Posted Date: June 19, 2018
• Last Update Posted Date: September 30, 2019
• Actual Study Start Date: July 20, 2018
• Estimated Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 8, 2018): 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 ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03562091 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 8, 2018)

• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• Progression (yes/no) of NET on imaging as part of the monitoring of the NET [ Time Frame: Month 3 and Month 6 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Subjects with Gastroenteropancreatic neuroendocrine tumor (GEPNET) from Primary care clinics
• Condition: 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).

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 8, 2018): 115
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2019
• Estimated Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ipsen Recruitment Enquiries; clinical.trials@ipsen.com

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03562091
• Other Study ID Numbers: A-FR-52030-371
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Ipsen
• Study Sponsor: Ipsen
• Collaborators: Not Provided

Investigators

• Study Director: Ipsen Medical Director; Ipsen

• PRS Account: Ipsen
• Verification Date: September 2019