Constructing a Multimodal Imaging System to Predict the Risk of Heterochronous Metastasis of Rect… (NCT06293612) | Clinical Trial Compass
CompletedNot Applicable
Constructing a Multimodal Imaging System to Predict the Risk of Heterochronous Metastasis of Rectal Cancer
China302 participantsStarted 2015-01-01
Plain-language summary
The goal of this observational study is to construct a multimodal intelligent model to predict the risk of heterochronous metastasis of rectal cancer, which is helpful for individualized diagnosis and treatment and follow-up planning. The main questions it aims to answer are:
* what are the independent risk factors of distant metastasis (DM) in locally advanced rectal cancer (LARC)
* What is the influence weight of the above factors on the heterochronous metastasis of LARC, and how to build a risk-prediction model
This study will not affect or interfere with the routine medical diagnosis and treatment of participants, and will not increase the cost and risk of participants. Participant's information is protected and identified by a unique code.
Who can participate
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:
* Newly diagnosed non-mucinous LARC (T3\~T4, or any T with N1\~2, M0) without previous treatment;
* No concomitant malignancies or systemic disease;
* Complete standard neoadjuvant chemoradiotherapy (NCRT) and radical surgery in our institute;
* Underwent rectal MRI and colonoscopy within 2 weeks before NCRT.
Exclusion Criteria:
* Fail to meet any of the inclusion criteria;
* Inadequate MR image quality for analysis, or lack of biopsy tissue for TSR assessment;
* Incomplete clinical data or withdraw before last visit.
A total of 578 eligible LARC cases were initially reviewed, 276 of which were excluded according to the exclusion criteria. Finally, 302 patients were enrolled in this study and randomized into a training cohort (n ＝ 211) and validation cohort (n ＝ 91).
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
1
Heterochronous distant metastasis
Timeframe: Through study completion, an average of 3 years
Trial details
NCT IDNCT06293612
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences