What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials

Recruiting

• Conditions: Solid Tumor
• Interventions: Other: Solid Tumor

• Registration Number: NCT06326242
• Lead Sponsor: European Institute of Oncology

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.

Study Timeline

• Study Start: 2023-03-27
• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Solid Tumor	Solid Tumor	Phase 1 patient with solid tumor

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

European Institute of oncology; 🇮🇹 Milano, Italy