NCT06515964

Brief Summary

With the development of endoscopy, more and more patients with superficial esophageal squamous cell carcinoma (ESCC) receive endoscopic resection rather than traditional surgery. However, there is still no complete consensus on the risk factors for lymph node metastasis (LNM) and recurrence of ESCC after endoscopic resection. The existing curative resection criteria are strict to a certain extent, and a considerable number of patients are overtreated according to the current standard of additional treatment. Thus, we aim to conduct a multi-center retrospective and prospective study to construct a large cohort of ESCC based on the previously established multi-center collaborative research network and clinical big data, analyze the risk factors of LNM and recurrence in patients with early esophageal squamous cell carcinoma after ESD, establish an accurate and simple risk prediction model, and evaluate the discrimination efficiency of this model.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

July 17, 2024

Last Update Submit

July 22, 2024

Conditions

Early Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Noncurative Resection

    Noncurative resection was defined as the presence of residual tumor or lymph node metastasis at the vertical margin of the lesion confirmed by pathology after surgery, or local recurrence, lymph node metastasis, or distant metastasis attributable to the primary tumor during follow-up.

    2022-12 Complete the preliminary clinical study preparation. 2023-10 Complete patient data analysis and sorting. 2024-10 Construct an accurate evaluation system. 2025-10 Conduct validation analysis of the evaluation system.

Interventions

observational studyOTHER

observational study, no intervention

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From January 2015 to December 2020, no less than 1400 patients who received ESD treatment for early esophageal squamous cell carcinoma were expected to be included.

You may qualify if:

  • Men and women, aged 18-85.
  • ESD was performed for early (superficial) esophageal squamous cell carcinoma, and the indication was in line with domestic and foreign guidelines.
  • The pathological stage after ESD was pT1a/pT1b.
  • The effective follow-up time after ESD was ≥3 years, or recurrence or LNM occurred during the follow-up period.

You may not qualify if:

  • Esophageal chemoradiotherapy or esophageal surgery were performed before ESD.
  • There is a history of carcinoma, early carcinoma, adenoma and other benign and malignant tumors of stomach and duodenum.
  • Pathological data after ESD were incomplete.
  • Combined with malignant tumors of other organs.
  • Fragmented endoscopic mucosal resection (EMR), multi-loop mucosal resection (MBM) and other endoscopic non-monolithic resection techniques were used.
  • New squamous cell carcinoma in other parts of esophagus during follow-up (metachronous carcinoma).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Luowei Wang, Doctor

CONTACT

13901833088wangluoweimd@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 23, 2024

Study Start

October 1, 2022

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)