Spatial Profile of Tumors (PROST)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Solid Tumors

Treatments: Other: Spatial analysis of paraffin samples from solid tumors

Study type: Observational

Funder types: Other

Identifiers

NCT06298773

6127

Details and patient eligibility

About

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®.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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