Prediction Model for Lateral Lymph Node Metastasis

Rectal Cancer Clinical Trial

Official title:

Radiomics-based Prediction Model for Lateral Lymph Node Metastasis in Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635488
• Other study ID #: LLNM-2020
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2020
• Source: West China Hospital
• Contact: Ziqiang Wang, MD
• Phone: 18980602028
• Email: wangziqiang[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. Radiomics parameters of lateral lymph nodes would be extracted by expert software. Then a part of the nodes would be used as the training set to build the prediction model, and the another part nodes would be used as the validation set.

Description:

After performing lateral lymph node dissection for the enrolled patients, we would find the targeted lateral node which was matched with the enlarged one in imaging from the specimen. Then the nodes would be send for pathological examination. Then we would extract the radiomics parameters of the nodes from the pretreatment CT and MRI with ITK-SNAP software. According to the pathological status, lymph nodes and corresponding radiomics parameters would be divided into positive and negative groups. Then significant parameters would be selected by R software. Then the prediction model with nomogram would be developed. 70% nodes would be used for for model development and the other 30% would be used for validation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• middle to low-lying rectal adenocarcinoma patients with enlarged lateral lymph node =5mm for short diameter in CT and/or MRI

Exclusion Criteria:

• other kind of rectal tumor including neuroendocrine and malignant.

• high location rectal cancer.

• recurrent rectal cancer

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• lateral lymph node dissection
All participted would receive lateral lymph node dissection for rectal cancer.

Locations

Country	Name	City	State
China	Guoxue Road 37#,West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metastasis rate of lateral lymph node		2020.1-2022.12.31