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Clinical Trials/NCT06192030
NCT06192030
Recruiting
Not Applicable

Machine Learning-based Model for Prediction of Survival and Mutations in Ovarian Metastases of Colorectal Cancer

Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country200 target enrollmentAugust 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Metastases of Colorectal Cancer
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Enrollment
200
Locations
1
Primary Endpoint
Disease-free survival
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 27, 2022
End Date
August 2025
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Disease-free survival

Time Frame: 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

Time Frame: 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

Time Frame: At least 3-year follow up

Overall survival was defined as the time from surgery to death, or to the last follow-up.

Secondary Outcomes

  • Rates of key gene mutation(At least 1-year follow up)

Study Sites (1)

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