EOCRCPred: an AI Model to Predict Survival in EOCRC Patients After Surgery

NCT ID: NCT06690606

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2025-05-11

Brief Summary

The goal of this observational study is to develop a predictive model for overall survival in patients under the age of 50 who have undergone surgery for early-onset colorectal cancer (EOCRC). The main question it aims to answer is:

Can machine learning models accurately predict the long-term survival of EOCRC patients after surgical treatment?

Participants who have already undergone surgery for EOCRC as part of their regular medical care will have their clinical data analyzed, with survival outcomes tracked through follow-up assessments. An online survival calculator will also be developed to aid clinicians and patients in predicting personalized survival outcomes.

Detailed Description

To avoid duplicating information that will be entered or uploaded elsewhere in the record, here is a concise summary of the key components of the study:

• Study Title**: *EOCRCPred: An AI Model to Predict Survival in Early-onset Colorectal Cancer Patients After Surgery*
• Introduction**:

This study addresses the increasing incidence and mortality of early-onset colorectal cancer (EOCRC) in patients under 50. EOCRC exhibits distinct clinical and pathological features compared to late-onset CRC, including higher recurrence rates and advanced disease stages at diagnosis. Current predictive models for postoperative outcomes in EOCRC are limited, highlighting the need for specialized tools to guide treatment decisions.

• Objectives**:

1. Develop AI models for predicting overall survival (OS) in postoperative M0 EOCRC patients.

2. Propose a new survival risk stratification system.

3. Deploy an online survival calculator to assist clinical decision-making.

• Methods**:

• **Data Source**: SEER database (2010-2019) for training/testing; two Chinese hospitals for external validation (2014-2024).
• **Inclusion Criteria**: Pathologically confirmed primary EOCRC, radical surgery (stage I-III), and complete follow-up.
• **Models**: Six predictive models, including CoxPH, RSF, S-SVM, XGBSE, GBSA, and DeepSurv.
• **Evaluation Metrics**: Discrimination (C-index, time-dependent AUC), calibration (Brier score, calibration curves), and clinical utility (Decision Curve Analysis).
• Statistical Analysis**:

Comparisons were made using t-tests, Mann-Whitney U tests, and chi-square tests, with P < 0.05 indicating significance.

**Risk Stratification**: Risk groups were classified based on RSF-derived scores (low, intermediate, high), and survival differences were assessed via Kaplan-Meier curves and log-rank tests.

This streamlined summary covers the primary goals, methodology, and analysis without repeating specifics that will be detailed in other sections of the record.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

external validation cohort

The external validation cohort was composed of primary EOCRC patients who underwent radical resection at Putuo Hospital and Yueyang Hospital, both affiliated with Shanghai University of Traditional Chinese Medicine. The cohort includes patients diagnosed between January 2014 and June 2024.

Inclusion criteria: Patients with pathologically confirmed primary EOCRC, aged under 50 years, and who received radical surgery (stages I-III according to the AJCC 7th edition).

Exclusion criteria: Patients with multiple primary cancers, survival time under 1 month, or missing critical data.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Primary EOCRC confirmed by pathological histological examination (ICD-10 codes: C18.0, C18.2-18.9, C19.9, C20.9)
• Radical surgery performed (Specific Surgery Codes 30-70, including partial/subtotal colectomy, hemicolectomy, right/left colectomy, and total colectomy, as well as partial or total removal of other organs and regional lymph nodes)
• Stage I-III disease according to the 7th AJCC-TNM system

Exclusion Criteria

• Patients with multiple primary cancers or other malignancies
• Survival time of less than 1 month, or absence of postoperative follow-up information
• Incomplete critical clinical feature information

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Wanli Deng, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wanli Deng

Role: PRINCIPAL_INVESTIGATOR

Putuo Hospital, Shanghai University of Traditional Chinese Medicine

Locations

Putuo Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, , China

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, , China

Countries

China

Central Contacts

Wanli Deng

Role: CONTACT

tcmdwl@163.com

+86 13166062368

Facility Contacts

Wanli Deng

Role: primary

Yabin Gong

Role: primary

gongyabin@hotmail.com

+86 18918923873

Other Identifiers

2021tszk01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-BSH-02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PTEC-A-2024-61 (S)

Identifier Type: -

Identifier Source: org_study_id