Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma(RENMIN-237)

NCT ID: NCT05980403

Last Updated: 2024-11-14

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

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-18

Study Completion Date

2024-12-18

Brief Summary

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Accurate assessment of lymph node status in superficial esophageal squamous cell carcinoma is of great significance for preventing undertreatment and overtreatment. However, the accuracy of the commonly used preoperative imaging methods for evaluating lymph node status is not high, and it is urgent to develop a prediction model that can predict the risk of individual lymph node metastasis to assist in clinical decision-making. In this context, investigators intend to retrospectively collect the clinical and pathological data of 300 patients with superficial esophageal squamous cell carcinoma, construct a lymph node metastasis risk prediction model. In addition, investigators are also preparing to prospectively collect tissue samples from 30 patients with superficial esophageal squamous cell carcinoma to further explore the mechanism of lymph node metastasis.

Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Lymph node metastasis negative

Superficial esophageal squamous cell carcinoma with negative lymph node metastasis

No interventions assigned to this group

Lymph node metastasis positive

Superficial esophageal squamous cell carcinoma with positive lymph node metastasis

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients diagnosed with esophageal cancer in Renmin Hospital of Wuhan University from 2013 to 2022.
2. Histopathological diagnosis was squamous cell carcinoma.
3. T1NxM0.
4. Received endoscopic resection or esophagectomy.

Exclusion Criteria

1. Patients who received neoadjuvant therapy.
2. Positive surgical margin.
3. Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured.
4. Lack of complete histopathological information.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yongshun Chen

OTHER

Sponsor Role lead

Responsible Party

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Yongshun Chen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Renmin hosptial of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongshun Chen, MD

Role: CONTACT

+8615327122084

Facility Contacts

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Liwei Chen

Role: primary

86+15671578311

Other Identifiers

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WDRY2023-K115

Identifier Type: -

Identifier Source: org_study_id

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