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Not yet recruiting NCT06298773

Spatial Profile of Tumors

Observational Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spatial analysis of paraffin samples from solid tumors.
Who it may be relevant to
Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other 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.

Primary outcome measures

  • Spatial analysis of cancer cells [Time frame: 7 days]
Secondary outcome measures (2)
  • Comparison of clinical data [Time frame: 1 day]
  • Identification of therapeutic targets [Time frame: 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome

Identifiers

NCT: NCT06298773 · 6127

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗