| NCT ID | NCT06515964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changhai Hospital |
| Condition | Early Esophageal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-10-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06515964 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 85 Years, studying Early Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06515964 currently recruiting?
Yes, NCT06515964 is actively recruiting participants. Contact the research team at wangluoweimd@126.com for enrollment information.
Where is the NCT06515964 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06515964 clinical trial?
NCT06515964 is sponsored by Changhai Hospital. The trial plans to enroll 1,000 participants.
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