China Early Esophageal Cancer Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-85
SponsorChanghai Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • observational study

    Other intervention

    observational study, no intervention

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhai Hospital

Lead sponsor

Lianshui People's Hospital

Collaborator

The second affiliated hospital of Xuzhou medical university

Collaborator

The second people's hospital of Nanyang

Collaborator

Nanchong Central Hospital

Collaborator

Tongliao City Hospital

Collaborator

Yancheng First People's Hospital

Collaborator

The Second Hospital of Hebei Medical University

Collaborator

The Second Affiliated Hospital of Baotou Medical College

Collaborator

Affiliated Hospital of Southwest Medical University

Collaborator

Sichuan Cancer Hospital and Research Institute

Collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborator

Zhongda Hospital

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Collaborator

West China Hospital

Collaborator

The First Affiliated Hospital of Soochow University

Collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

Collaborator

Shandong Provincial Hospital

Collaborator

Shanxi Provincial People's Hospital

Collaborator

Henan Provincial People's Hospital

Collaborator

Anyang Cancer Hospital

Collaborator