NCT07165210

Brief Summary

the study was to document the incidence of left tracheobronchial lymph node metastasis, and the risk factors of metastasis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,852

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Jul 2025

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jul 2025Jul 2030

Study Start

First participant enrolled

July 21, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2030

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 3, 2025

Last Update Submit

September 3, 2025

Conditions

Esophageal Cancer

Keywords

lymph node metastasisesophagectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of left tracheobronchial lymph node metastasis

    number of patients who had left tracheobronchial lymph node metastasis/number of patients who had resection of left tracheobronchial lymph node

    2 years

Secondary Outcomes (2)

  • Risk factors of left tracheobronchial lymph node metastasis

    2 years

  • Survival of patients with left tracheobronchial lymph node metastasis

    5 years

Study Arms (1)

prospective observation cohort

All patients who had surgery due to esophageal cancer with curative intent, no intervention was applied.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational CohortOTHER

no intervention was applied in this cohort

prospective observation cohort

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

observation study population

You may qualify if:

  • patients with esophageal squamous cell carcinoma
  • clinical staging: cT1-4a N0/+ M0.
  • no history of other malignancy.

You may not qualify if:

  • esophageal cancer in the neck
  • poor physical status to have esophagectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Bin Li, MD

CONTACT

086-021-64175590-82500lb0256327@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Institute of Thoracic Oncology, Fudan University

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

July 21, 2025

Primary Completion (Estimated)

July 21, 2027

Study Completion (Estimated)

July 21, 2030

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

incidence, risk factors and survival data could be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
the IPD and supporting information will be available from January 1st 2027 to December 31st 2030.

Locations

CN(1)