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NCT Number: NCT06298773

Spatial Profile of Tumors

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®.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, 00168, Italy

Location contact

Alessandro Sgambato

CONTACT

[email protected]

+390630154914

Alessandro Sgambato

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spatial analysis of paraffin samples from solid tumors

Other

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 outcomes

  1. Spatial analysis of cancer cells

    Time frame: 7 days

    Spatial distribution analysis of the main cell subpopulations characterising the tumours studied.

Secondary outcomes

  1. Comparison of clinical data

    Time frame: 1 day

    Correlation of spatial analysis data with patient clinical data

  2. Identification of therapeutic targets

    Time frame: 4 weeks

    Identification of possible therapeutic targets of different subpopulations

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Sgambato

CONTACT

[email protected]

+390630154914

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: PROST

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Mar 7, 2024
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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