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

NCT07351708 | Completed

• 2 other identifiers: 2025ZSLYEC-724No.82573589
• Study Type: observational
• Target: 2,315
• Locations: 0 countries
• Sites: N/A

Brief 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 neoadjuvant therapy followed by total mesorectal excision.

Conditions

Locally Advanced Rectal Cancer (LARC)

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of randomization until the date of death from local recurrence, assessed up to 120 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cai Zerong: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

The pathological specimens before operation and the specimens after operation

Study Officials

• Zerong Cai, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of the Department

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 20, 2026
• Study Start: January 6, 2010
• Primary Completion: December 30, 2022
• Study Completion: November 30, 2025
• Last Updated: January 20, 2026

Record last verified: 2010-01

Data Sharing

• IPD Sharing: Will not share