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

European Institute of Oncology

Status

Enrolling

Conditions

Solid Tumor

Treatments

Other: Solid Tumor

Study type

Observational

Funder types

Other

Identifiers

NCT06326242

IEO 1648

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and 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.