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OpenTrials
Completed

NCT Number: NCT03562091

Perception of Information and Quality of Life in Neuroendocrine Tumour 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.

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ipsen Central Contact

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: OPERA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2018
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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