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Starting soon Observational

Spatial Profile of Tumors

NCT06298773 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-03-05
Last updated
2024-03-07

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

Spatial analysis of paraffin samples from solid tumors

Spatial analysis of paraffin samples from solid tumors: The intervention involves the collection of tumour samples included in paraffin present in the pathological anatomy archive or requested to external archives for samples older than 2003 and the subsequent multiparametric spatial analysis of the main populations of the microenvironment tumor.

Study summary

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®.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Spatial analysis of cancer cells — 7 days
    Spatial distribution analysis of the main cell subpopulations characterising the tumours studied.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome RM
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06298773 on ClinicalTrials.gov ↗ ← All trials in Italy