Spatial Profile of Tumors

NCT ID: NCT06298773

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-05

Study Completion Date

2028-12-30

Brief Summary

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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

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Conditions

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Solid Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alessandro Sgambato

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, Italy

Site Status

Countries

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Italy

Central Contacts

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Alessandro Sgambato

Role: CONTACT

+390630154914

Facility Contacts

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Alessandro Sgambato

Role: primary

+390630154914

Other Identifiers

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6127

Identifier Type: -

Identifier Source: org_study_id

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