Solid Tumors Clinical Trial
— PROSTOfficial title:
SPATIAL PROFILE OF SUBPOPULATIONS OF CANCER AND IMMUNITARY CELLS IN SEVERAL SOLID TUMORS
The research project focuses on analyzing the spatial organization of cells within various solid tumors, utilizing advanced technologies enabling in-depth multi-parametric analysis of tumor and immune cells. The primary objective is to understand the spatial distribution of cellular subpopulations within each type of tumor, while secondary objectives include correlating these data with clinical aspects and identifying potential therapeutic targets. The study involves 1000 patients with primary or metastatic tumors and spans a duration of 5 years, from 2024 to 2028. No experimental treatments are planned; rather, only spatial imaging analyses with multiple markers will be conducted. Data analysis involves descriptive statistical methods and hypothesis testing to generate hypotheses for subsequent studies. The analyses will be performed using SPSS® version 21.0 software for Windows®.
| Status | Not yet recruiting |
| Enrollment | 1000 |
| Est. completion date | December 30, 2028 |
| Est. primary completion date | September 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - male or female subjects aged 18 years - primary or metastatic tumors Diagnosed by histology and/or radiological evidence, RNM, or endoscopic - signature of informed consent - substitute declaration to the consent form where applicable Exclusion Criteria: - previous unrelated tumour disease - significant acute or chronic infections (HIV, HCV and HBV infections) and/or ongoing bacterial and viral infections - active autoimmune disease - pregnant or breastfeeding - patients who do not sign informed consent |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | RM |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Spatial analysis of cancer cells | Spatial distribution analysis of the main cell subpopulations characterising the tumours studied. | 7 days | |
| Secondary | Comparison of clinical data | Correlation of spatial analysis data with patient clinical data | 1 day | |
| Secondary | Identification of therapeutic targets | Identification of possible therapeutic targets of different subpopulations | 4 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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