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

NCT06314750 | Completed

• 1 other identifier: 2023ZSLYEC-680
• Study Type: observational
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Locally Advanced Rectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• OS

  Overall Survival

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

Study Arms (2)

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.

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

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.

You may qualify if:

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

You may not qualify if:

• lack of clinical TNM staging information or other key clinical information about MRI
• the imaging quality is poor or the MRI image has artifacts

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: 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: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 18, 2024
• Study Start: January 1, 2010
• Primary Completion: September 30, 2023
• Study Completion: June 30, 2025
• Last Updated: August 14, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share