Prediction Model for Lateral Lymph Node Metastasis

Sichuan University

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: lateral lymph node dissection

Study type: Observational

Funder types: Other

Identifiers

NCT04635488

LLNM-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Trainning group

Description:

70% of the whole participants would be randomly divided into the training group to build the predicition model.

Treatment:

Procedure: lateral lymph node dissection

validation group

Description:

30% of the whole participant would be divided into the validation group to validate the model

Treatment:

Procedure: lateral lymph node dissection