Locally Advanced Rectal Cancer (LARC)PROMISE modelNCT07351708
Development and Validation of a Post-operative Risk Of Local Recurrence Model Integrating Serology and Evalution (PROMISE) in Local Advanced Rectal Cancer Receiving Neoadjuvant Therapy: a Multicenter Study
An observational study of Locally Advanced Rectal Cancer (LARC), run by Cai Zerong.
Trial summary
Local recurrence (LR) in locally advanced rectal cancer (LARC) correlated with poor survival and impaired quality of life. The aim of this study was to develop and validate machine learning (ML) models integrating clinicopathological features and inflammatory signature to predict LR in LARC patients undergoing… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- How many people
- 2,315 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2010to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eight hundred and sixty-nine patients (median [interquartile range] age, 57 [48, 64] years; 70% [611/869] male) with LARC between January 2010 and December 2022 in SYSU6H served as the training cohort, while 1446 patients with LARC between January 2010 and December 2022 in CHH (median age, 62 [54, 69]; 62% [902/1446] male) were served as the validation cohort.
Who may be able to join
- Diagnosed cT>=3 or cN+ stage rectal cancer by pelvic MRI or enhanced CT scan;
- Pathological proved primary rectal adenocarcinoma;
- Recieved full-cource radiation or more than 3 cycles of chemotherapy before surgery;
- Recieved radical tumor resection by TME surgery.
Who cannot join
- Diganosed with any distant metastasis disease or locally unresectable disease before neoadjuvant treatment or surgery;
- Recieved local resection surgery (R2 resection) or postoperative pathology confirmed positive surgical margins (R1 resection);
- Patients who died due to intra- or post-operative complications;
- Patient who die or relapse within 30 days after surgery;
- Patients who had a prior history of malignancy within 5 years before surgery;
- Patients who were loss of follow-up or had inadequate clinical data.
About this study
Local recurrence (LR) in locally advanced rectal cancer (LARC) correlated with poor survival and impaired quality of life. The aim of this study was to develop and validate machine learning (ML) models integrating clinicopathological features and inflammatory signature to predict LR in LARC patients undergoing neoadjuvant therapy followed by total mesorectal excision.
Read the detailed description
To address the gap in accessible and integrative risk prediction, this study aimed to develop and validate an interpretable machine learning model for the early prediction of postoperative local recurrence in LARC patients using a multicenter cohort. We employed SHapley Additive exPlanations (SHAP) analysis to elucidate feature importance and provide clear interpretations for individual predictions, with the ultimate goal of evaluating the model's clinical utility in guiding personalized patient management-particularly by identifying high-risk patients in clinical practice and informing tailored follow-up and treatment strategies to improve patient outcomes.
- Conditions
- Locally Advanced Rectal Cancer (LARC)
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 |
|---|---|---|
| LR patients | Local recurrence (LR) was defined as recurrent rectal cancer within the pelvic, including-but not limited to- lateral nodal recurrence, presacral recurrence, anastomotic recurrence, or perineal recurrence. | |
| non-LR patients | Local recurrence (LR) was defined as recurrent rectal cancer within the pelvic, including-but not limited to- lateral nodal recurrence, presacral recurrence, anastomotic recurrence, or perineal recurrence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence
Local recurrence (LR) was defined as recurrent rectal cancer within the pelvic, including-but not limited to- lateral nodal recurrence, presacral recurrence, anastomotic recurrence, or perineal recurrence.
Measured: From date of randomization until the date of death from local recurrence, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start6 Jan 2010
- Primary completion30 Dec 2022
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal Cancer (LARC)Studies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cai Zerong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cai Zerong, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Zerong Cai, MD, Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351708
- Sponsor's protocol ID
- 2025ZSLYEC-724
- Other IDs
- No.82573589
- Acronym
- PROMISE model
- Status last verified
- Jan 2010
- First submitted
- 12 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Please contact us by Email.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Post-operative Risk Of Local Recurrence Model Integrating Serology and Evalution (PROMISE) in Local Advanced Rectal Cancer Receiving Neoadjuvant Therapy: a Multicenter Study
- ClinicalTrials.gov ID
- NCT07351708
- Acronym / sponsor ID
- PROMISE model / 2025ZSLYEC-724
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,315 participants (actual)
- Lead sponsor
- Cai ZerongUniversity, hospital or other
- Study start
- 6 Jan 2010 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 20 Jan 2026 (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.
Local recurrence (LR) in locally advanced rectal cancer (LARC) correlated with poor survival and impaired quality of life. The aim of this study was to develop and validate machine learning (ML) models integrating clinicopathological features and inflammatory signature to predict LR in LARC patients undergoing neoadjuvant therapy followed by total mesorectal excision.
Detailed description
To address the gap in accessible and integrative risk prediction, this study aimed to develop and validate an interpretable machine learning model for the early prediction of postoperative local recurrence in LARC patients using a multicenter cohort. We employed SHapley Additive exPlanations (SHAP) analysis to elucidate feature importance and provide clear interpretations for individual predictions, with the ultimate goal of evaluating the model's clinical utility in guiding personalized patient management-particularly by identifying high-risk patients in clinical practice and informing tailored follow-up and treatment strategies to improve patient outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LR patients | – | –Local recurrence (LR) was defined as recurrent rectal cancer within the pelvic, including-but not limited to- lateral nodal recurrence, presacral recurrence, anastomotic recurrence, or perineal recurrence. |
| non-LR patients | – | –Local recurrence (LR) was defined as recurrent rectal cancer within the pelvic, including-but not limited to- lateral nodal recurrence, presacral recurrence, anastomotic recurrence, or perineal recurrence. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eight hundred and sixty-nine patients (median [interquartile range] age, 57 [48, 64] years; 70% [611/869] male) with LARC between January 2010 and December 2022 in SYSU6H served as the training cohort, while 1446 patients with LARC between January 2010 and December 2022 in CHH (median age, 62 [54, 69]; 62% [902/1446] male) were served as the validation cohort.
Key inclusion criteria (4 listed)
- Diagnosed cT>=3 or cN+ stage rectal cancer by pelvic MRI or enhanced CT scan;
- Pathological proved primary rectal adenocarcinoma;
- Recieved full-cource radiation or more than 3 cycles of chemotherapy before surgery;
- Recieved radical tumor resection by TME surgery.
Key exclusion criteria (6 listed)
- Diganosed with any distant metastasis disease or locally unresectable disease before neoadjuvant treatment or surgery;
- Recieved local resection surgery (R2 resection) or postoperative pathology confirmed positive surgical margins (R1 resection);
- Patients who died due to intra- or post-operative complications;
- Patient who die or relapse within 30 days after surgery;
- Patients who had a prior history of malignancy within 5 years before surgery;
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
Local recurrence
Time frame: From date of randomization until the date of death from local recurrence, assessed up to 120 months
Local recurrence (LR) was defined as recurrent rectal cancer within the pelvic, including-but not limited to- lateral nodal recurrence, presacral recurrence, anastomotic recurrence, or perineal recurrence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. Please contact us by Email.
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Locally Advanced Rectal Cancer (LARC)
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. This study is not recruiting at the moment.
Zerong Cai, MD study director
Sixth Affiliated Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Rectal Cancer (LARC), run by Cai Zerong.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence (time frame: From date of randomization until the date of death from local recurrence, assessed up to 120 months). 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 20 Jan 2026.