Machine Learning Predicts Survival and Mutations in Ovarian Metastases of Colorectal Cancer

Recruiting

• Conditions: Ovarian Metastases of Colorectal Cancer
• Interventions: Other: Prediction model

• Registration Number: NCT06192030
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

The study aimed to develop and validate models to predict survival outcome and key mutations in patients with ovarian metastases of colorectal cancer, as well as to compare the differential gene expression between long-survival group and short-survival group.

Detailed Description

The investigator performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict survival outcome and key mutations from multimodality data in patients with ovarian metastases of colorectal cancer. Secondly, the investigator aimed to compare the differential gene expression between long-survival group and short-survival group.

Study Timeline

• Study Start: 2022-08-27
• Study First Submitted: 2023-10-09
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Histologically confirmed colorectal cancer
• Unilateral or bilateral ovarian masses confirmed by peroperative imaging examination
• Patient requiring resection of their ovarian and/or peritoneal carcinomatosis
• 18 ≤ Age ≤ 85
• World Health Organization performance status ≤ 1
• Life expectancy > 12 weeks
• Adequate haematological, liver and renal function
• Patient information and signature of the informed consent form before the start of any treatment procedures

Exclusion Criteria

• Ovarian metastases of origin other than colorectal
• Primary ovarian tumor
• Clinical data missing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective cohort	Prediction model	The same inclusion/exclusion criteria were applied for the same center prospectively. It is a validation cohort.
Retrospective cohort	Prediction model	The cohort was retrospectively enrolled in The Sixth Affiliated Hospital, Sun Yat-sen University from August 2010 to August 2022. It is a training cohort.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	At least 1-year follow up	Disease-free survival was defined as the interval between surgery and the first peritoneal or distant relapse or death from any cause.
Peritoneal-free survival	At least 1-year follow up	Peritoneal-free survival was defined as the interval between surgery and the first peritoneal relapse. Ovarian metastasis has been shown to be a subtype of peritoneal metastasis.
Overall survival	At least 3-year follow up	Overall survival was defined as the time from surgery to death, or to the last follow-up.

Secondary Outcome Measures

Name	Time	Method
Rates of key gene mutation	At least 1-year follow up	Rates of key gene mutation, such as microsatellite instability-high/DNA mismatch repair

Trial Locations

Locations (1)

Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China