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An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solid Tumor | Phase 1 patient with solid tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solid Tumor | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO). | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The characterization of enrolled patients involves assessing their participation in clinical trials | 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 |
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Inclusion Criteria :
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.
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Patient enrolled in a phase 1 and early phase 2 study at our institution.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Profeta | Contact | +390294372561 | teresa.profeta@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Teresa Profeta | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of oncology | Recruiting | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| C412868 | PMEPA1 protein, human |
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|
| 1 year |
| The characterization of enrolled patients based on therapeutic compliance. | The evaluation of compliance with protocol procedures unrelated to the administration of the experimental drug, such as pharmacokinetic sampling and study biopsies | 1 year |
| The protocol prescriptions in relation to socioeconomic and geographical determinants. | 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. | 1 year |