NCT06690606

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 12, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2025

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 12, 2024

Last Update Submit

November 13, 2024

Conditions

Keywords

AI modelpredictionEarly-Onset Colorectal Cancer (EOCRC)postoperative survivalsurgery

Outcome Measures

Primary Outcomes (1)

  • Assessment of Clinical Characteristics and Survival Status of Subjects Using the CRF Scale

    Age, Gender, Race, Primary Site, Tumor Diameter, Differentiation Degree, Histology, TNM Stage, CEA, Surgery Type, Number of Resected Lymph Nodes, Tumor Deposits, Neural Invasion, Radiation Sequence, Chemotherapy Sequence, Systemic Therapy Sequence, Marital Status, Household Income, Survival Status, Postoperative Survival Time.

    2024.11

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with early-onset, Stage I-III colorectal cancer who underwent radical resection at Putuo Hospital and Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, both affiliated with Shanghai University of Traditional Chinese Medicine, were retrospectively collected between January 2014 and June 2024.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Putuo Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, 200062, China

Location

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, 200062, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Wanli Deng

    Putuo Hospital, Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 15, 2024

Study Start

November 12, 2024

Primary Completion

May 11, 2025

Study Completion

May 11, 2025

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations