CompletedNot Applicable

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

2,315 participantsStarted 2010-01-06

Plain-language 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.

Who can participate

Age range

20 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Local recurrence

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

Trial details

NCT IDNCT07351708

SponsorCai Zerong

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Locally Advanced Rectal Cancer (LARC) trials