China Early Esophageal Cancer Cohort

NCT ID: NCT06515964

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

observational study

observational study, no intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lianshui People's Hospital

UNKNOWN

Sponsor Role collaborator

The second affiliated hospital of Xuzhou medical university

UNKNOWN

Sponsor Role collaborator

The second people's hospital of Nanyang

UNKNOWN

Sponsor Role collaborator

Nanchong Central Hospital

OTHER_GOV

Sponsor Role collaborator

Tongliao City Hospital

UNKNOWN

Sponsor Role collaborator

Yancheng First People's Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Baotou Medical College

OTHER

Sponsor Role collaborator

Affiliated Hospital of Southwest Medical University

OTHER

Sponsor Role collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Zhongda Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Shanxi Provincial People's Hospital

OTHER_GOV

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Anyang Cancer Hospital

UNKNOWN

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Luowei Wang, Doctor

Role: CONTACT

13901833088

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lei Xin, MD

Role: primary

13817318134

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEEC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Changhai Multimodal Esophageal Cancer Cohort
NCT06410677 ACTIVE_NOT_RECRUITING