Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Proportion of patients with locally advanced inoperable and/or metastatic PDAC undergoing palliative second line therapy after progression on first line chemotherapy |
|
24 months |
|
Secondary |
To identify prognostic and predictive features for treatment efficacy |
|
24 months |
|
Secondary |
To identify prognostic and predictive features for clinical outcome |
|
24 months |
|
Secondary |
To identify prognostic and predictive features for Neuropathy |
Relative frequency of Grade 3 and Grade 4 Adverse Events according to the Common Terminology Criteria of Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To identify prognostic and predictive features for Febrile Neuropathy |
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To identify prognostic and predictive features for Thrombocytopenia |
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To identify prognostic and predictive features for Anemia |
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To identify prognostic and predictive features for Nausea/Vomiting |
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To identify prognostic and predictive features for Skin toxicity |
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To identify prognostic and predictive features for rash |
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To identify prognostic and predictive features for mucositis |
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To identify prognostic and predictive features for Fatigue |
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To identify prognostic and predictive features for Allergic reactions |
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To identify prognostic and predictive features for all other Adverse Events |
Relative frequency of Grade 3 and Grade 4 Adverse Events (CTCAE) will be documented |
24 months |
|
Secondary |
To investigate the effect of dose density on treatment efficacy of first- and second line therapy |
|
24 months |
|
Secondary |
To investigate the effect of dose modifications on treatment efficacy of first- and second line therapy |
|
24 months |
|
Secondary |
To perform a comparative effectiveness analysis of different palliative second line chemotherapy regimens |
|
24 months |
|
Secondary |
To evaluate treatment behaviours after progression on palliative second line therapy |
|
24 months |
|
Secondary |
To analyse efficacy of palliative third line therapy |
|
24 months |
|
Secondary |
To analyse patterns of BRCA testing in real-world practice |
|
24 months |
|
Secondary |
To analyse the impact of BRCA testing in real-world practice on treatment decisions |
|
24 months |
|
Secondary |
To analyse the impact of BRCA testing in real-world practice on outcome |
|
24 months |
|
Secondary |
Prevalence of primary tumor resection in patients with metastatic or locally advanced inoperable pancreatic cancer |
|
24 months |
|
Secondary |
Prevalence of metastasectomy in patients with metastatic or locally advanced inoperable pancreatic cancer |
|
24 months |
|
Secondary |
To evaluate the impact of primary tumor resection on outcome |
|
24 months |
|
Secondary |
To evaluate the impact of metastasectomy on outcome |
|
24 months |
|
Secondary |
To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on dose density of FOLFIRINOX |
|
24 months |
|
Secondary |
To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on rate of febrile neutropenia |
|
24 months |
|
Secondary |
To evaluate the impact of primary granulocyte-colony stimulating factor (G-CSF) use on overall outcome |
|
24 months |
|
Secondary |
To evaluate patterns of molecular profiling in the real world treatment practice of advanced pancreatic cancer |
|
24 months |
|
Secondary |
To evaluate patterns of next generation sequencing (NGS) in the real world treatment practice of advanced pancreatic cancer |
|
24 months |
|
Secondary |
To analyse treatment patterns and outcome in the subgroup of very young (<40 years old) patients with advanced pancreatic cancer |
|
24 months |
|
Secondary |
To analyse treatment patterns and outcome in the subgroup of very old (>75 years old) patients with advanced pancreatic cancer |
|
24 months |
|
Secondary |
To investigate the impact of diabetes mellitus on treatment efficacy of palliative chemotherapy and disease outcome |
|
24 months |
|
Secondary |
To investigate the impact of antidiabetic therapy on treatment efficacy of palliative chemotherapy and disease outcome |
|
24 months |
|
Secondary |
To analyze the mutational landscape of advanced pancreatic cancer and its impact on treatment decision making and clinical outcome |
|
24 months |
|