CClinicalTrials.gg
Status unknownNCT04635488Updated Nov 19, 2020

Prediction Model for Lateral Lymph Node Metastasis

An observational study in Rectal Cancer, sponsored by West China Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-11-19.

Sponsored by West China Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rectal Cancer

Keywords

  • rectal cancer
  • lymph node metastasis
  • prediction model
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 200 is above the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with rectal cancer.

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

Exclusion Criteria:

  • other kind of rectal tumor including neuroendocrine and malignant.
  • high location rectal cancer.
  • recurrent rectal cancer
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • validation group

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

    Procedure: lateral lymph node dissection

Interventions

  • Procedurelateral lymph node dissection

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

06

What researchers measure

Primary outcomes

  1. metastasis rate of lateral lymph node

    Time frame: 2020.1-2022.12.31

07

Study locations

1 of 1 sites recruiting
  • Guoxue Road 37#,West China Hospital
    Chengdu, Sichuan 610041, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — individual participant data (IPD) would not be available to other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04635488
Lead sponsor
West China Hospital
Responsible party
Ziqiang Wang,MD (MD, West China Hospital) — Principal investigator
First posted
Nov 19, 2020
Start date
Jan 1, 2020
Primary completion
Jun 30, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Nov 19, 2020

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion