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.
Study Type
OBSERVATIONAL
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Oddział w Gliwicach
Gliwice, Poland
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland
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 \[RECIST 1.0\])
Time frame: 12 months
Median PFS
Time frame: 24 months
Tumour origin
Time frame: 24 months
Tumour grade
Time frame: 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".
Time frame: 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 \[SD\]).
Time frame: 24 months
Chromogranin A (CgA) level
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Świętokrzyskie Centrum Onkologii
Kielce, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, Poland
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu
Poznan, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego
Szczecin, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Centralny Szpital Kliniczny
Warsaw, Poland
...and 1 more locations
Time frame: 24 months
Urine 5-hydroxyindoleaceticacid (5-HIAA) levels
Time frame: 24 months