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Prediction Model for Lateral Lymph Node Metastasis

NCT ID: NCT04635488

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rectal Cancer

Keywords

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rectal cancer lymph node metastasis prediction model

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Trainning group

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

lateral lymph node dissection

Intervention Type PROCEDURE

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

lateral lymph node dissection

Intervention Type PROCEDURE

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

Interventions

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lateral lymph node dissection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ziqiang Wang,MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guoxue Road 37#,West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ziqiang Wang, MD

Role: CONTACT

Phone: 18980602028

Email: [email protected]

Xubing Zhang, MD

Role: CONTACT

Phone: 18428374478

Email: [email protected]

Facility Contacts

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Ziqiang Wang, MD

Role: primary

Other Identifiers

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LLNM-2020

Identifier Type: -

Identifier Source: org_study_id