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Reassessment of study feasibility
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The main aim of this study is to assess the Progression-Free Survival (PFS) at 12 months of Lanreotide Autogel 120 mg use when administered as part of routine GEP-NET treatment and to follow patient treatment pathways, identify prognostic factors of PFS, evaluate patient's QoL, and patient's and clinician's satisfaction with treatment in routine long-term care setting. The study will provide real-world evidence on the use of Lanreotide Autogel 120 mg and will provide information on topics such as optimization of product usage and identification of best practices and will provide evidence on product effectiveness in a realistic setting.
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | To estimate the rate according to investigator assessment (radiological progression; based on Response Evaluation Criteria In Solid Tumours version 1.0 [RECIST 1.0]) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median PFS | 24 months | |
| Tumour origin | 24 months | |
| Tumour grade |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects with GEP-NETs eligible for treatment with Lanreotide Autogel 120 mg or currently being treated with Lanreotide Autogel 120 mg every 28 days for a period of up to 5 months. Subjects will receive treatment as prescribed by the physician and in accordance with the current Summary of Product Characteristics (SmPC).
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80952 | Poland | |||
| Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Oddział w Gliwicach |
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| 24 months |
| Quality of Life (QoL) | To describe the change in Quality of Life (QoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire for gastrointestinal neuroendocrine tumours (QLQ-GINET21 questionnaires). Where the patient assess experienced symptoms or problems using the scale from 1 to 4. Where 1 represents "not at all" and 4 "very much". | 24 months |
| Disease Control Rate | To estimate the Disease Control Rate (DCR), as assessed by investigator (proportion of subjects with a best overall response of Partial Response [PR], Complete Response [CR] or Stable Disease [SD]). | 24 months |
| Chromogranin A (CgA) level | 24 months |
| Patients' satisfaction | To evaluate patients' satisfaction using abbreviated 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). It assesses key dimensions of treatment satisfaction: Effectiveness, Convenience and Global Satisfaction. The effectiveness scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the convenience scored as 1 (extremely difficult) to 7 (extremely easy). | 24 months |
| Urine 5-hydroxyindoleaceticacid (5-HIAA) levels | 24 months |
| Gliwice |
| 44102 |
| Poland |
| Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach | Katowice | 40514 | Poland |
| Świętokrzyskie Centrum Onkologii | Kielce | 25734 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 31501 | Poland |
| SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi | Lodz | 92213 | Poland |
| Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu | Poznan | 60355 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego | Szczecin | 71252 | Poland |
| Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie | Warsaw | 02034 | Poland |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Centralny Szpital Kliniczny | Warsaw | 02097 | Poland |
| Dolnośląskie Centrum Onkologii we Wrocławiu | Wroclaw | 53413 | Poland |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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