Clinical trial · Observational
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
NCT07351708CI-TRIAL-00101196PROMISE modelcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer (LARC) | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- LR patients
- description
- 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.
- label
- non-LR patients
- description
- 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.
Primary outcomes (1)
- measure
- Local recurrence
- timeFrame
- From date of randomization until the date of death from local recurrence, assessed up to 120 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed cT\>=3 or cN+ stage rectal cancer by pelvic MRI or enhanced CT scan; 2. Pathological proved primary rectal adenocarcinoma; 3. Recieved full-cource radiation or more than 3 cycles of chemotherapy before surgery; 4. Recieved radical tumor resection by TME surgery. Exclusion Criteria: 1. Diganosed with any distant metastasis disease or locally unresectable disease before neoadjuvant treatment or surgery; 2. Recieved local resection surgery (R2 resection) or postoperative pathology confirmed positive surgical margins (R1 resection); 3. Patients who died due to intra- or post-operative complications; 4. Patient who die or relapse within 30 days after surgery; 5. Patients who had a prior history of malignancy within 5 years before surgery; 6. Patients who were loss of follow-up or had inadequate clinical data.
References
Publications (0)
Data not yet available
No reference posted for this study.