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Spatial Profile of Tumors

SPATIAL PROFILE OF SUBPOPULATIONS OF CANCER AND IMMUNITARY CELLS IN SEVERAL SOLID TUMORS

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06298773
Acronym
PROST
Enrollment
1000
Registered
2024-03-07
Start date
2024-03-05
Completion date
2028-12-30
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Brief 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®.

Interventions

OTHERSpatial 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.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Spatial analysis of cancer cells7 daysSpatial distribution analysis of the main cell subpopulations characterising the tumours studied.

Secondary

MeasureTime frameDescription
Comparison of clinical data1 dayCorrelation of spatial analysis data with patient clinical data
Identification of therapeutic targets4 weeksIdentification of possible therapeutic targets of different subpopulations

Countries

Italy

Contacts

Primary ContactAlessandro Sgambato
alessandro.sgambato@policlinicogemelli.it+390630154914

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026