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

Last updated: March 20, 2024
Sponsor: European Institute of Oncology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neuroblastoma

Treatment

Solid Tumor

Clinical Study ID

NCT06326242
IEO 1648
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Solid Tumor
Phase:
Study Start date:
March 27, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • European Institute of oncology

    Milano, 20141
    Italy

    Active - Recruiting

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