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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-27

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating Disparities in Precision Oncology

NCT06081517

Metastatic Cancer Advanced Cancer

RECRUITING

Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement

NCT04879927

Breast Cancer Lung Cancer Gastrointestinal Cancer

COMPLETED NA

Facilitate the Return to Work of Cancer Survivors

NCT03666936

Neoplasms Return to Work

COMPLETED NA

Addressing Social Determinants of Health Among Metro Detroit Cancer Survivors

NCT06908629

Cancer Cancer Survivors Gastrointestinal Cancers +2 more

RECRUITING NA

Evaluating Patient Participation in Phase I Clinical Trials

NCT00043030

Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Solid Tumor

Phase 1 patient with solid tumor

Solid Tumor

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes