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Prediction Model for Lateral Lymph Node Metastasis

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ClinicalTrials.gov Identifier: NCT04635488
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Ziqiang Wang,MD, West China Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Rectal Cancer Procedure: lateral lymph node dissection

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiomics-based Prediction Model for Lateral Lymph Node Metastasis in Rectal Cancer
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Trainning group
70% of the whole participants would be randomly divided into the training group to build the predicition model.
 Procedure: lateral lymph node dissection
All participted would receive lateral lymph node dissection for rectal cancer.
validation group
30% of the whole participant would be divided into the validation group to validate the model
 Procedure: lateral lymph node dissection
All participted would receive lateral lymph node dissection for rectal cancer.


Outcome Measures
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Primary Outcome Measures :
  1. metastasis rate of lateral lymph node [ Time Frame: 2020.1-2022.12.31 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with rectal cancer.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635488


Contacts
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Contact: Ziqiang Wang, MD 18980602028 wangziqiang@scu.edu.cn
Contact: Xubing Zhang, MD 18428374478 2421770462@qq.com

Locations
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China, Sichuan
Guoxue Road 37#,West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Ziqiang Wang, MD    18980602028    wangziqiang@scu.edu.cn   
Sponsors and Collaborators
West China Hospital
More Information
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Responsible Party: Ziqiang Wang,MD, MD, West China Hospital
ClinicalTrials.gov Identifier: NCT04635488    
Other Study ID Numbers: LLNM-2020
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participant data (IPD) would not be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziqiang Wang,MD, West China Hospital:
rectal cancer
lymph node metastasis
prediction model
Additional relevant MeSH terms:
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Neoplasm Metastasis
Rectal Neoplasms
Lymphatic Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases