Clinical trial NCT06515964: China Early Esophageal Cancer Cohort
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Early Esophageal Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Lianshui People's Hospital
name: The second affiliated hospital of Xuzhou medical university
name: The second people's hospital of Nanyang
name: Nanchong Central Hospital
name: Tongliao City Hospital
name: Yancheng First People's Hospital
name: The Second Hospital of Hebei Medical University
name: The Second Affiliated Hospital of Baotou Medical College
name: Affiliated Hospital of Southwest Medical University
name: Sichuan Cancer Hospital and Research Institute
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Zhongda Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: West China Hospital
name: The First Affiliated Hospital of Soochow University
name: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Shandong Provincial Hospital
name: Shanxi Provincial People's Hospital
name: Henan Provincial People's Hospital
name: Anyang Cancer Hospital
First posted: 2024-07-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Noncurative Resection
timeFrame: 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:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References: