Colorectal CancerNCT06690606
EOCRCPred: an AI Model to Predict Survival in EOCRC Patients After Surgery
An observational study of Colorectal Cancer, run by Shanghai University of Traditional Chinese Medicine at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 250 participants
- Where
- 2 sitesChina
- Study dates
- 12 Nov 2024to 11 May 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Putuo Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, 200062
Wanli Deng
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, 200062
Yabin Gong, +86 18918923873, gongyabin@hotmail.com
About this study
Official title: EOCRCPred: an AI Model for Predicting Overall Survival in Early-Onset Stage I-III Colorectal Cancer Patients Post-Radical Resection-A SEER Database and Dual-Center Chinese Medical Institutions Study
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.
Read the 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**:
- Develop AI models for predicting overall survival (OS) in postoperative M0 EOCRC patients.
- Propose a new survival risk stratification system.
- 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
- Keywords
- AI model, prediction, Early-Onset Colorectal Cancer (EOCRC), postoperative survival, surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2024.11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start12 Nov 2024 (estimated)
- Primary completion11 May 2025 (estimated)
- Study completion11 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanli Deng, MD, Shanghai University of Traditional Chinese Medicine
- Investigators
- Wanli Deng, Principal investigator, Putuo Hospital, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690606
- Sponsor's protocol ID
- PTEC-A-2024-61 (S)
- Other IDs
- 2021tszk01, 2023-BSH-02
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share Individual Participant Data (IPD) has not been finalized due to several considerations. We are evaluating factors such as privacy and confidentiality risks, even with anonymization, as well as the ethical and legal implications of data sharing. Additionally, we must assess whether participants' consent allows for broader data sharing beyond the initial study purpose. These factors are under review, and a final decision will be made with careful consideration of participant protection and compliance with regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EOCRCPred: an AI Model for Predicting Overall Survival in Early-Onset Stage I-III Colorectal Cancer Patients Post-Radical Resection-A SEER Database and Dual-Center Chinese Medical Institutions Study
- ClinicalTrials.gov ID
- NCT06690606
- Acronym / sponsor ID
- PTEC-A-2024-61 (S)
- Conditions
- Colorectal Cancer
- Keywords
- AI model, prediction, Early-Onset Colorectal Cancer (EOCRC), postoperative survival, surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 12 Nov 2024 (estimated)
- Primary completion
- 11 May 2025 (estimated)
- Study completion
- 11 May 2025 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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**:
- Develop AI models for predicting overall survival (OS) in postoperative M0 EOCRC patients.
- Propose a new survival risk stratification system.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Clinical Characteristics and Survival Status of Subjects Using the CRF Scale
Time frame: 2024.11
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: Undecided. The decision to share Individual Participant Data (IPD) has not been finalized due to several considerations. We are evaluating factors such as privacy and confidentiality risks, even with anonymization, as well as the ethical and legal implications of data sharing. Additionally, we must assess whether participants' consent allows for broader data sharing beyond the initial study purpose. These factors are under review, and a final decision will be made with careful consideration of participant protection and compliance with regulatory requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wanli Deng principal investigator
Putuo Hospital, Shanghai University of Traditional Chinese Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Shanghai University of Traditional Chinese Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanli Deng (+86 13166062368, tcmdwl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Clinical Characteristics and Survival Status of Subjects Using the CRF Scale (time frame: 2024.11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.