NCT06256185

Brief Summary

Existing models do poorly when it comes to quantifying the risk of Lymph node metastases (LNM). This study generated elastic net regression (ELR), random forest (RF), extreme gradient boosting (XGB), and a combined (ensemble) model of these for LNM in patients with T1 esophageal squamous cell carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,267

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 15, 2010

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

9.9 years

First QC Date

January 23, 2024

Last Update Submit

February 9, 2024

Conditions

Lymph Node Metastasis

Outcome Measures

Primary Outcomes (3)

  • Model performance: discrimination

    Draw the ROC curve of the model and obtain their AUC values, and select the best prediction model based on the results of the validation set

    8 weeks

  • Variable importance

    Calculate the importance level of variables used in the model and sort them, and analyze the reasons for the most important variables

    6 weeks

  • Sub-analysis (ML Model vs. Logistic Model vs. NCCN Guideline)

    Apply NCCN guidelines and logistic models for prediction, and compare their performance with the model obtained in this study to determine the actual application benefits of the model

    8 weeks

Study Arms (1)

Arm used for predicting lymph node metastasis

EXPERIMENTAL
Procedure: esophagectomy

Interventions

esophagectomyPROCEDURE

Resection of esophageal tumor and lymph node dissection

Arm used for predicting lymph node metastasis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • (I) thoracic ESCC
  • (II) no history of concomitant or prior malignancy
  • (III) tumor with pT1 staging
  • (IV) 15 or more lymph nodes examined

You may not qualify if:

  • underwent neoadjuvant treatment or endoscopic submucosal dissection before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (19)

  • Erratum: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2020 Jul;70(4):313. doi: 10.3322/caac.21609. Epub 2020 Apr 6. No abstract available.

    PMID: 32767693BACKGROUND

  • Ohashi S, Miyamoto S, Kikuchi O, Goto T, Amanuma Y, Muto M. Recent Advances From Basic and Clinical Studies of Esophageal Squamous Cell Carcinoma. Gastroenterology. 2015 Dec;149(7):1700-15. doi: 10.1053/j.gastro.2015.08.054. Epub 2015 Sep 12.

    PMID: 26376349BACKGROUND

  • Merkow RP, Bilimoria KY, Keswani RN, Chung J, Sherman KL, Knab LM, Posner MC, Bentrem DJ. Treatment trends, risk of lymph node metastasis, and outcomes for localized esophageal cancer. J Natl Cancer Inst. 2014 Jul 16;106(7):dju133. doi: 10.1093/jnci/dju133. Print 2014 Jul.

    PMID: 25031273BACKGROUND

  • Alvarez Herrero L, Pouw RE, van Vilsteren FG, ten Kate FJ, Visser M, van Berge Henegouwen MI, Weusten BL, Bergman JJ. Risk of lymph node metastasis associated with deeper invasion by early adenocarcinoma of the esophagus and cardia: study based on endoscopic resection specimens. Endoscopy. 2010 Dec;42(12):1030-6. doi: 10.1055/s-0030-1255858. Epub 2010 Oct 19.

    PMID: 20960392BACKGROUND

  • Gamboa AM, Kim S, Force SD, Staley CA, Woods KE, Kooby DA, Maithel SK, Luke JA, Shaffer KM, Dacha S, Saba NF, Keilin SA, Cai Q, El-Rayes BF, Chen Z, Willingham FF. Treatment allocation in patients with early-stage esophageal adenocarcinoma: Prevalence and predictors of lymph node involvement. Cancer. 2016 Jul 15;122(14):2150-7. doi: 10.1002/cncr.30040. Epub 2016 May 3.

    PMID: 27142247BACKGROUND

  • Dubecz A, Kern M, Solymosi N, Schweigert M, Stein HJ. Predictors of Lymph Node Metastasis in Surgically Resected T1 Esophageal Cancer. Ann Thorac Surg. 2015 Jun;99(6):1879-85; discussion 1886. doi: 10.1016/j.athoracsur.2015.02.112. Epub 2015 Apr 28.

    PMID: 25929888BACKGROUND

  • Zheng H, Tang H, Wang H, Fang Y, Shen Y, Feng M, Xu S, Fan H, Ge D, Wang Q, Tan L. Nomogram to predict lymph node metastasis in patients with early oesophageal squamous cell carcinoma. Br J Surg. 2018 Oct;105(11):1464-1470. doi: 10.1002/bjs.10882. Epub 2018 Jun 4.

    PMID: 29863776BACKGROUND

  • Duan X, Shang X, Yue J, Ma Z, Chen C, Tang P, Jiang H, Yu Z. A nomogram to predict lymph node metastasis risk for early esophageal squamous cell carcinoma. BMC Cancer. 2021 Apr 20;21(1):431. doi: 10.1186/s12885-021-08077-z.

    PMID: 33879102BACKGROUND

  • Collins GS, Dhiman P, Andaur Navarro CL, Ma J, Hooft L, Reitsma JB, Logullo P, Beam AL, Peng L, Van Calster B, van Smeden M, Riley RD, Moons KG. Protocol for development of a reporting guideline (TRIPOD-AI) and risk of bias tool (PROBAST-AI) for diagnostic and prognostic prediction model studies based on artificial intelligence. BMJ Open. 2021 Jul 9;11(7):e048008. doi: 10.1136/bmjopen-2020-048008.

    PMID: 34244270BACKGROUND

  • Jiang KY, Huang H, Chen WY, Yan HJ, Wei ZT, Wang XW, Li HX, Zheng XY, Tian D. Risk factors for lymph node metastasis in T1 esophageal squamous cell carcinoma: A systematic review and meta-analysis. World J Gastroenterol. 2021 Feb 28;27(8):737-750. doi: 10.3748/wjg.v27.i8.737.

    PMID: 33716451BACKGROUND

  • Pavlou M, Ambler G, Seaman SR, Guttmann O, Elliott P, King M, Omar RZ. How to develop a more accurate risk prediction model when there are few events. BMJ. 2015 Aug 11;351:h3868. doi: 10.1136/bmj.h3868.

    PMID: 26264962BACKGROUND

  • van Vliet EP, Heijenbrok-Kal MH, Hunink MG, Kuipers EJ, Siersema PD. Staging investigations for oesophageal cancer: a meta-analysis. Br J Cancer. 2008 Feb 12;98(3):547-57. doi: 10.1038/sj.bjc.6604200. Epub 2008 Jan 22.

    PMID: 18212745BACKGROUND

  • Choi J, Kim SG, Kim JS, Jung HC, Song IS. Comparison of endoscopic ultrasonography (EUS), positron emission tomography (PET), and computed tomography (CT) in the preoperative locoregional staging of resectable esophageal cancer. Surg Endosc. 2010 Jun;24(6):1380-6. doi: 10.1007/s00464-009-0783-x. Epub 2009 Dec 24.

    PMID: 20033712BACKGROUND

  • Ou J, Wu L, Li R, Wu CQ, Liu J, Chen TW, Zhang XM, Tang S, Wu YP, Yang LQ, Tan BG, Lu FL. CT radiomics features to predict lymph node metastasis in advanced esophageal squamous cell carcinoma and to discriminate between regional and non-regional lymph node metastasis: a case control study. Quant Imaging Med Surg. 2021 Feb;11(2):628-640. doi: 10.21037/qims-20-241.

    PMID: 33532263BACKGROUND

  • Wang S, Chen X, Fan J, Lu L. Prognostic Significance of Lymphovascular Invasion for Thoracic Esophageal Squamous Cell Carcinoma. Ann Surg Oncol. 2016 Nov;23(12):4101-4109. doi: 10.1245/s10434-016-5416-8. Epub 2016 Jul 19.

    PMID: 27436201BACKGROUND

  • Li B, Chen H, Xiang J, Zhang Y, Kong Y, Garfield DH, Li H. Prevalence of lymph node metastases in superficial esophageal squamous cell carcinoma. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1198-203. doi: 10.1016/j.jtcvs.2013.07.006. Epub 2013 Aug 26.

    PMID: 23988285BACKGROUND

  • Shen W, Shen Y, Tan L, Jin C, Xi Y. A nomogram for predicting lymph node metastasis in surgically resected T1 esophageal squamous cell carcinoma. J Thorac Dis. 2018 Jul;10(7):4178-4185. doi: 10.21037/jtd.2018.06.51.

    PMID: 30174862BACKGROUND

  • Akutsu Y, Uesato M, Shuto K, Kono T, Hoshino I, Horibe D, Sazuka T, Takeshita N, Maruyama T, Isozaki Y, Akanuma N, Matsubara H. The overall prevalence of metastasis in T1 esophageal squamous cell carcinoma: a retrospective analysis of 295 patients. Ann Surg. 2013 Jun;257(6):1032-8. doi: 10.1097/SLA.0b013e31827017fc.

    PMID: 23108117BACKGROUND

  • Emi M, Hihara J, Hamai Y, Furukawa T, Ibuki Y, Okada M. Clinicopathologic Features of Submucosal Esophageal Squamous Cell Carcinoma. Ann Thorac Surg. 2017 Dec;104(6):1858-1864. doi: 10.1016/j.athoracsur.2017.06.037. Epub 2017 Oct 21.

    PMID: 29033014BACKGROUND

MeSH Terms

Conditions

Lymphatic Metastasis

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 13, 2024

Study Start

January 15, 2010

Primary Completion

December 15, 2019

Study Completion

July 15, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)