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NCT Number: NCT06515964

China Early Esophageal Cancer Cohort

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.

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Key information

Conditions

Early Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Lei Xin, MD

CONTACT

[email protected]

13817318134

Luowei Wang, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

observational study

Other

observational study, no intervention

Primary outcomes

  1. Noncurative Resection

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luowei Wang, Doctor

CONTACT

[email protected]

13901833088

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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