Solid Tumor
Conditions
Brief summary
An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.
Detailed description
The study focuses on defining the problem of geographical accessibility of patients to the Phase 1 facility of the European Institute of Oncology, based on an anonymized extraction of data from the enrolled patient database, to assess national territorial disparities in access to innovative experimental therapies, in relation to various socioeconomic determinants. Finally, information on relevant psychological factors for participation in clinical trials will also be collected.
Interventions
OTHERSolid Tumor
The study focuses on defining the problem of geographical accessibility of patients to the Phase 1 facility of the European Institute of Oncology, based on anonymized data extraction from the enrolled patient database, to evaluate national territorial disparities in access to innovative experimental therapies, in relation to various socioeconomic determinants. Finally, relevant information on psychological factors for participation in clinical trials will also be collected.
Sponsors
European Institute of Oncology
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Patient with a histological or cytological diagnosis of solid or hematological tumor. * Age ≥ 18 years. * Patient enrolled in a phase 1 and early phase 2 study at our institution. * The patient has received at least 1 administration of the experimental drug under study in the early phase trial.
Exclusion criteria
: \- Patients treated in phase 1 trials at other institutions, even if referred to our division or receiving standard therapies at IEO but outside of clinical trials, are not included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO). | 1 year | The primary endpoint is estimating the geographical distance from the enrolled patients' residences to the European Institute of Oncology (IEO), evaluating patients from the Lombardy region versus those from other regions with an assessment by geographical cluster: north, central, south, and islands, in order to define any preferential trajectories or recurring patterns. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The characterization of enrolled patients involves assessing their participation in clinical trials | 1 year | The enrolled patients will be characterized based on psychological factors included in the study. These factors include: patient attitudes, perceived social norms, and perceived control over participation in clinical studies; doctor-patient relationship; study awareness; evaluation of their own decision to participate in the study |
| The characterization of enrolled patients based on therapeutic compliance. | 1 year | The evaluation of compliance with protocol procedures unrelated to the administration of the experimental drug, such as pharmacokinetic sampling and study biopsies |
| The protocol prescriptions in relation to socioeconomic and geographical determinants. | 1 year | The correlations with metrics of geographic accessibility and income per area of origin will be explored in accordance with ISTAT (Italian National Statistics Institute) data, where applicable. |
Countries
Italy
Contacts
Primary ContactTeresa Profeta
Outcome results
None listed