NCT04635488

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

November 13, 2020

Last Update Submit

November 18, 2020

Conditions

Keywords

rectal cancerlymph node metastasisprediction model

Outcome Measures

Primary Outcomes (1)

  • metastasis rate of lateral lymph node

    2020.1-2022.12.31

Study Arms (2)

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

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

Trainning groupvalidation group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with rectal cancer.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guoxue Road 37#,West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ziqiang Wang, MD

CONTACT

Xubing Zhang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 19, 2020

Study Start

January 1, 2020

Primary Completion

June 30, 2021

Study Completion

December 31, 2022

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

individual participant data (IPD) would not be available to other researchers.

Locations