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Trial record 82 of 2802 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT03562091
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : September 30, 2019
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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