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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326242
• Other study ID #: IEO 1648
• Status: Recruiting
• Start date: March 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Teresa Profeta
• Phone: +390294372561
• Email: teresa.profeta[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
Italy	European Institute of oncology	Milano

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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