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

NCT06326242 | Recruiting

• 1 other identifier: IEO 1648
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The characterization of enrolled patients involves assessing their participation in clinical trials

  1 year

• The characterization of enrolled patients based on therapeutic compliance.

  1 year

• The protocol prescriptions in relation to socioeconomic and geographical determinants.

  1 year

Study Arms (1)

Solid Tumor

Phase 1 patient with solid tumor

Other: Solid Tumor

Interventions

Solid Tumor OTHER

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.

Solid Tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of oncology

Milan, 20141, Italy

RECRUITING

MeSH Terms

Interventions

PMEPA1 protein, human

Study Officials

• Teresa Profeta

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Profeta

CONTACT

+390294372561; teresa.profeta@ieo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 22, 2024
• Study Start: March 27, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

IT (1)