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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

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
Neuroendocrine Tumors Other: Data collection

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Study Type : Observational
Estimated 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 : July 20, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019



Intervention Details:
  • 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).


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Progression (yes/no) of NET on imaging as part of the monitoring of the NET [ Time Frame: Month 3 and Month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with Gastroenteropancreatic neuroendocrine tumor (GEPNET) from Primary care clinics
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562091


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

Locations
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France
Ipsen Central Contact Recruiting
Paris, France
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03562091     History of Changes
Other Study ID Numbers: A-FR-52030-371
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Lanreotide
Angiopeptin
Antineoplastic Agents