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

NCT06192030 | Unknown

• 1 other identifier: wanghm7
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Metastases of Colorectal Cancer

Keywords

Krukenberg tumor

Outcome Measures

Primary Outcomes (3)

• Overall survival

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

  At least 3-year follow up

• Disease-free survival

  Disease-free survival was defined as the interval between surgery and the first peritoneal or distant relapse or death from any cause.

  At least 1-year follow up

• Peritoneal-free survival

  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.

  At least 1-year follow up

Secondary Outcomes (1)

• Rates of key gene mutation

  At least 1-year follow up

Study Arms (2)

Retrospective cohort

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.

Other: Prediction model

Prospective cohort

The same inclusion/exclusion criteria were applied for the same center prospectively. It is a validation cohort.

Other: Prediction model

Interventions

Prediction model OTHER

We develop and validate clinical models to predict patient survival and gene signatures in ovarian metastases of colorectal cancer.

Prospective cohort; Retrospective cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ovarian metastases from colorectal cancer

You may qualify if:

• Histologically confirmed colorectal cancer
• Unilateral or bilateral ovarian masses confirmed by peroperative imaging examination
• Patient requiring resection of their ovarian and/or peritoneal carcinomatosis
• ≤ 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Primary tumor, metastatic tissue and normal tissue

MeSH Terms

Conditions

Krukenberg Tumor

Condition Hierarchy (Ancestors)

Carcinoma, Signet Ring Cell; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Central Study Contacts

Yuanxin Zhang, MD

CONTACT

8617372001179; zyx163yxdz@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: January 5, 2024
• Study Start: August 27, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

CN (1)