Clinical trial · Observational
What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials
Toward a Patient-centered Early Drug Development in Oncology: What Unmet Need for the Patients? A Focus on the Social Determinants of Health in Phase 1 Clinical Trials
NCT06326242CI-TRIAL-00075315unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Solid Tumor | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Solid Tumor
- description
- Phase 1 patient with solid tumor
- interventionNames
- Other: Solid Tumor
Primary outcomes (1)
- measure
- The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO).
- timeFrame
- 1 year
- description
- 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 outcomes (3)
- measure
- The characterization of enrolled patients involves assessing their participation in clinical trials
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.