Spatial Profile of Tumors (PROST)

March 1, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

SPATIAL PROFILE OF SUBPOPULATIONS OF CANCER AND IMMUNITARY CELLS IN SEVERAL SOLID 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®.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Alessandro Sgambato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will be 1000 adult male and female patients with primary or metastatic neoplastic pathology of the following types of cancer: lung cancer, colon cancer, salivary gland cancer, hepatocarcinoma, sarcomas, osteosarcomas, breast cancer, glioblastoma, kidney cancer, pancreatic cancer, neck cancer.

The patient samples that will be examined in the study are derived from biopsies that patients have been subjected to according to their treatment plan.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatial analysis of cancer cells
Time Frame: 7 days
Spatial distribution analysis of the main cell subpopulations characterising the tumours studied.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of clinical data
Time Frame: 1 day
Correlation of spatial analysis data with patient clinical data
1 day
Identification of therapeutic targets
Time Frame: 4 weeks
Identification of possible therapeutic targets of different subpopulations
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Alessandro Sgambato, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 5, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 6127

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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