Development and Validation of a PSN-AI Prediction Model (PSN-AI)

Development and Validation of a AI Prognostic Model Based on DNA Ploidy, Stroma, and Nucleotyping for Synchronous Peritoneal Metastasis From Colorectal Cancer

Heterogeneity concerning survival in synchronous peritoneal metastasis from patients with colorectal cancer exists, thereby further classification is urgently required. This study aimed to validate a PSN-AI model based on DNA ploidy, stroma-tumor fraction, and nucleotyping (PSN) for the prediction of survival of synchronous peritoneal metastasis from colorectal cancer.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Peritoneal Metastases
• Intervention / Treatment: Other: Analyse pathologic slides

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Qiyuan Qin, PhD; Phone Number: +86-20-38254052; Email: qinqy3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Qiyuan Qin, M.D.; Phone Number: 86-20-38254052; Email: qinqy3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.

Description

Inclusion Criteria:

• Histological proof of synchronous peritoneal metastases of a nonappendiceal colorectal adenocarcinoma.
• Resectable disease determined by computed tomography (CT) and a peritoneal cancer index (PCI) of ≤20 at diagnostic laparoscopy or laparotomy;
• No evidence of systemic (e.g. liver, lung) colorectal metastases within three months prior to enrolment;
• Undergoing cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.

Exclusion Criteria:

• Combined with other types of malignant tumors.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Validation cohort; A cohort of consecutive patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model validation.	Other: Analyse pathologic slides; HE-stained whole slide images were used for the validation of the PSN-AI model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The time between the date of diagnosis and the date of death (due to any cause) or the date of last follow-up.	At least 1-year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	The time from diagnosis to the onset of disease progression.	At least 1-year follow up

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Synchronous peritoneal metastasis; DNA ploidy; Stroma-tumor fraction; Nucleotyping
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: PSN2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No