Skip to content

China Early Esophageal Cancer Cohort

Development and Validation of a Curability Evaluation Model for Endoscopic Resection of Early Esophageal Squamous Cell Carcinoma Based on China Early Esophageal Cancer Cohort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06515964
Enrollment
1000
Registered
2024-07-23
Start date
2022-10-01
Completion date
2025-10-01
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Esophageal Cancer

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.

Interventions

OTHERobservational study

observational study, no intervention

Sponsors

Lianshui People's Hospital
CollaboratorUNKNOWN
The second affiliated hospital of Xuzhou medical university
CollaboratorUNKNOWN
The second people's hospital of Nanyang
CollaboratorUNKNOWN
Nanchong Central Hospital
CollaboratorOTHER_GOV
Tongliao City Hospital
CollaboratorUNKNOWN
Yancheng First People's Hospital
CollaboratorOTHER
The Second Hospital of Hebei Medical University
CollaboratorOTHER
The Second Affiliated Hospital of Baotou Medical College
CollaboratorOTHER
Affiliated Hospital of Southwest Medical University
CollaboratorOTHER
Sichuan Cancer Hospital and Research Institute
CollaboratorOTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
CollaboratorOTHER
Zhongda Hospital
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
The First Affiliated Hospital of Soochow University
CollaboratorOTHER
Jiangsu Province Hospital of Traditional Chinese Medicine
CollaboratorOTHER
Shandong Provincial Hospital
CollaboratorOTHER_GOV
Shanxi Provincial People's Hospital
CollaboratorOTHER_GOV
Henan Provincial People's Hospital
CollaboratorOTHER
Anyang Cancer Hospital
CollaboratorUNKNOWN
Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Men and women, aged 18-85. 2. ESD was performed for early (superficial) esophageal squamous cell carcinoma, and the indication was in line with domestic and foreign guidelines. 3. The pathological stage after ESD was pT1a/pT1b. 4. The effective follow-up time after ESD was ≥3 years, or recurrence or LNM occurred during the follow-up period.

Exclusion criteria

1. Esophageal chemoradiotherapy or esophageal surgery were performed before ESD. 2. There is a history of carcinoma, early carcinoma, adenoma and other benign and malignant tumors of stomach and duodenum. 3. Pathological data after ESD were incomplete. 4. Combined with malignant tumors of other organs. 5. Fragmented endoscopic mucosal resection (EMR), multi-loop mucosal resection (MBM) and other endoscopic non-monolithic resection techniques were used. 6. New squamous cell carcinoma in other parts of esophagus during follow-up (metachronous carcinoma).

Design outcomes

Primary

MeasureTime frameDescription
Noncurative Resection2022-12 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.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.

Countries

China

Contacts

Primary ContactLuowei Wang, Doctor
wangluoweimd@126.com13901833088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026