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CompletedNCT06314750Updated Aug 14, 2025

Deep Learning Based MRI Radiomics in Predicting the Clinical Risk of Locally Advanced Rectal Cancer

An observational study in Locally Advanced Rectal Carcinoma, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Completed. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
186
Ages
20 Years to 90 Years
Sex
All
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Study summary

Neoadjuvant therapy is the standard diagnosis and treatment strategy for locally advanced rectal cancer defined by MRI in order to achieve tumor regression, thus affecting the selection of surgical strategy and circumferential margin, improving the safety of operation and the prognosis of patients. This study focused on the related clinical factors such as tumor regression before and after neoadjuvant therapy, combined with preoperative high-dimensional features such as radiomics, to predict the related factors of tumor regression of locally advanced rectal cancer, and validate it with multicenter. In order to develop an accurate model that can be applied to the real world and stratify the risk of locally advanced rectal cancer patients before treatment.

Read the detailed description

The patients with locally advanced rectal cancer were collected retrospectively, and the relevant information such as clinical baseline characteristics, imaging data and preoperative/postoperative pathological data were collected and integrated, applying the method of deep learning to construct the model, in order to predict and evaluate the risk factors (invasion of mesorectal fascia, status of cancer nodule, long-term prognosis, tumor recurrence, etc.) which are important in clinical diagnosis and treatment. After the model was established, prospective studies were carried out to validate the model, continue training and enrich the effectiveness of the model.

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Conditions studied

  • Locally Advanced Rectal Carcinoma
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In context

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A total of 136 patients (Well T-downstage: 28.68%, 39/136) were included in the training cohort and 50 (Well T-downstage: 30%, 15/50) patients in the test cohort.

Inclusion criteria

  1. Primary rectal adenocarcinoma was diagnosed before operation
  2. Preoperative MRI staging was diagnosed as stage cT4 rectal cancer
  3. Receiving neoadjuvant therapy before operation (including but not limited to chemotherapy, radiotherapy, immunotherapy or targeted therapy, etc.)
  4. Middle and low rectal cancer (the distance between the lower margin of the tumor and the anal margin ≤ 12cm measured by MRI)
  5. Receive radical resection of rectal cancer

Exclusion criteria

Exclusion Criteria:

  1. lack of clinical TNM staging information or other key clinical information about MRI
  2. the imaging quality is poor or the MRI image has artifacts
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
186 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Well T-downstage

    After receiving neoadjuvant therapy, the postoperative pathological stage of patients with primary cT4 rectal cancer was pT2 or less.

  • Poor T-downstage

    After receiving neoadjuvant therapy, the postoperative pathological stage of patients with primary cT4 rectal cancer was pT3 or above.

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What researchers measure

Primary outcomes

  1. OS

    Overall Survival

    Time frame: From date of randomization until the date of death from any cause, assessed up to 120 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Please contact us by Email

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06314750
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible party
Cai Zerong (Deputy Director of the Department, Sixth Affiliated Hospital, Sun Yat-sen University) — Principal investigator
First posted
Mar 18, 2024
Start date
Jan 1, 2010
Primary completion
Sep 30, 2023
Completion
Jun 30, 2025
Last update
Aug 14, 2025

Study contacts

Zerong Cai, MD
study director · Sixth Affiliated Hospital, Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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