Development and Validation of a PSN-AI Prediction Model

Colorectal Cancer Clinical Trial

— PSN-AI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231524
• Other study ID #: PSN2023
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: January 2024
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Qiyuan Qin, PhD
• Phone: +86-20-38254052
• Email: qinqy3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 1, 2025
• Est. primary completion date: December 30, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis
• Peritoneal Metastases

Intervention

Other:
• Analyse pathologic slides
HE-stained whole slide images were used for the validation of the PSN-AI model.

Locations

Country	Name	City	State
China	Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free survival	The time from diagnosis to the onset of disease progression.	At least 1-year follow up