ArTificial inTelligence-based RAdiogenomics in Colon Tumors

NCT06108310 | Unknown

• 1 other identifier: IG24974
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to develop an artificial intelligence-based model to assess radiogenomics signature of colon tumor in patients with stage II-III colon cancer. The main question it aims to answer is:

• Can artificial intelligence-based algorithm of radiomics features combined with clinical factors, biochemical biomarkers, and genomic data recognise tumor behaviour, aggressiveness, and prognosis, identifying a radiogenomics signature of the tumor? Participants will
• undergo a preoperative contrast-enhanced CT examination;
• undergo surgical excision of colon cancer
• undergo adjuvant therapy if deemed necessary based on current guidelines

Conditions

Colon Cancer Stage II; Colon Cancer Stage III

Keywords

colon cancer; artificial intelligence; segmentation; computed tomography

Outcome Measures

Primary Outcomes (1)

• Identification of radiogenomics signature (ATTRACT AI-model) of stage II-III colon tumors

  From January 2021 to December 2023

Secondary Outcomes (1)

• Correlation of radiogenomics signature (ATTRACT AI-model) of colon cancer with clinical outcomes (DFS and RFS)

  From January 2024 to December 2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The training phase will consist of a retrospective selection of three-hundred patients with pathologically proven stage II and III colon cancer from an institutional database. Test and validation will consist of a prospective data collection form a new patient population. Patients' recruitment will be performed by the Oncologic Unit and Unit of Surgery of Sant'Andrea Hospital - Sapienza University of Rome. Pathology and genomic will be extracted from the sample obtained during surgery and blood samples for ctDNA analysis will be collected before and during chemotherapy/follow up visits (within 30 day after colorectal surgery, after 3 and then every 6 months)

You may qualify if:

• patients with pathologically proven stage II and stage III colon cancer;
• availability of a CT scan with portal-venous phase at the time of diagnosis;
• availability of immunohistochemical panel

You may not qualify if:

• patients with no CT images prior to surgical resection;
• patients with CT scans characterized by motion artifacts preventing radiomics analysis

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Associazione Italiana per la Ricerca sul Cancro: collaborator

Study Sites (1)

AOU Sant'Andrea

Roma, RM, 00189, Italy

RECRUITING

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MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Andrea Laghi, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Laghi, MD

CONTACT

+390633775285‬; andrea.laghi@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: October 31, 2023
• Study Start: January 2, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

IT (1)