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

An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Other: Solid Tumor

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Teresa Profeta; Phone Number: +390294372561; Email: teresa.profeta@ieo.it

Study Locations

• Italy
  • Milano, Italy, 20141
    • Recruiting
    • European Institute of Oncology
    • Contact: Teresa Profeta; Phone Number: +390294372561

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patient enrolled in a phase 1 and early phase 2 study at our institution.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Solid Tumor; Phase 1 patient with solid tumor

Other: Solid 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Teresa Profeta, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IEO 1648

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No