Solid TumorNCT06326242
What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials
An observational study of Solid Tumor, run by European Institute of Oncology at 1 site in Italy.
Trial summary
An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Solid Tumor
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 27 Mar 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient enrolled in a phase 1 and early phase 2 study at our institution.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of oncology
Milan, 20141
Teresa Profeta, +390294372561
About this study
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
An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.
Read the detailed 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.
- Conditions
- Solid Tumor
- Being tested
- Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solid TumorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Solid Tumor | Phase 1 patient with solid tumor Receives: Other: Solid Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start27 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Profeta, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326242
- Sponsor's protocol ID
- IEO 1648
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06326242
- Acronym / sponsor ID
- IEO 1648
- Conditions
- Solid Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solid Tumor | – | Other: Solid TumorPhase 1 patient with solid tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient enrolled in a phase 1 and early phase 2 study at our institution.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solid TumorThe 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. | Other | Solid Tumor |
Primary outcome
The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO).
Time frame: 1 year
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.
3 secondary outcomes
The characterization of enrolled patients involves assessing their participation in clinical trials
Time frame: 1 year
The characterization of enrolled patients based on therapeutic compliance.
Time frame: 1 year
The protocol prescriptions in relation to socioeconomic and geographical determinants.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Profeta principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Profeta (+390294372561, teresa.profeta@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.