Spatial Profile of Tumors

Not yet recruiting

• Conditions: Solid Tumors

• Registration Number: NCT06298773
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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®.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study Start: 2024-03-05
• Study First Posted: 2024-03-07
• Last Update Posted: 2024-03-07
• Primary Completion: 2026-09-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spatial analysis of cancer cells	7 days	Spatial distribution analysis of the main cell subpopulations characterising the tumours studied.

Secondary Outcome Measures

Name	Time	Method
Identification of therapeutic targets	4 weeks	Identification of possible therapeutic targets of different subpopulations
Comparison of clinical data	1 day	Correlation of spatial analysis data with patient clinical data

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, RM, Italy