Development and Validation of a PSN-AI Prediction Model

NCT ID: NCT06231524

Last Updated: 2024-01-30

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

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Peritoneal Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Validation cohort

A cohort of consecutive patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model validation.

Analyse pathologic slides

Intervention Type OTHER

HE-stained whole slide images were used for the validation of the PSN-AI model.

Interventions

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Analyse pathologic slides

HE-stained whole slide images were used for the validation of the PSN-AI model.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiyuan Qin, PhD

Role: CONTACT

+86-20-38254052

Facility Contacts

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Qiyuan Qin, M.D.

Role: primary

86-20-38254052

Other Identifiers

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PSN2023

Identifier Type: -

Identifier Source: org_study_id

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