Examining social factors affecting access to Phase 1 cancer treatments
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
This study looks at how social and economic factors affect people's ability to access early-stage cancer treatments at the European Institute of Oncology.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT06326242 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the geographical accessibility of patients to Phase 1 clinical trials at the European Institute of Oncology. It aims to analyze disparities in access to innovative therapies based on socioeconomic determinants and to gather data on psychological factors influencing patient participation. By extracting anonymized data from enrolled patients, the study seeks to highlight unmet needs in the patient population regarding access to experimental treatments for solid tumors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of solid or hematological tumors who are enrolled in a Phase 1 or early Phase 2 clinical trial at the European Institute of Oncology.
Not a fit: Patients treated in Phase 1 trials at other institutions or those receiving standard therapies outside of clinical trials will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of barriers to access for patients in clinical trials, potentially leading to enhanced strategies for patient recruitment and support.
How similar studies have performed: While this study focuses on social determinants of health in clinical trial access, similar studies have shown that addressing these factors can lead to improved patient outcomes and participation rates.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milano
- European Institute of oncology — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Teresa Profeta — European Institute of Oncology
- Study coordinator: Teresa Profeta
- Email: teresa.profeta@ieo.it
- Phone: +390294372561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.