Primary Tumor Burden Score:A Novel Staging Parameter for ESCC After nCRT

NCT ID: NCT05839002

Last Updated: 2023-05-03

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

COMPLETED

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-21

Study Completion Date

2023-03-15

Brief Summary

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In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS).

Detailed Description

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In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS), which will combine the proportion of residual primary tumor cells and pre-treatment pathological T stage (prepT stage). The investigators will also try to improve ypTNM stage by results of PTBS.

Conditions

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Neoplasm, Esophagus Neoplasm, Squamous Cell

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Training cohort

Training cohort will be used to find the best calculation and cut-off values for PTBS in ESCC after nCRT.

nCRT

Intervention Type PROCEDURE

ESCC patients that recieved surgery and nCRT.

Validation cohort

The study's conclusion will be verified in Zhongshan Hospital Xiamen branch.

nCRT

Intervention Type PROCEDURE

ESCC patients that recieved surgery and nCRT.

Interventions

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nCRT

ESCC patients that recieved surgery and nCRT.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- Neoadjuvant chemoradiotherapy and surgical resection of esophageal squamous cell carcinoma

Exclusion Criteria

* Patients receiving neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma without surgical resection
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xu Huang

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Huang X, Jiang D, Sun T, Zhou G, Zeng Z, Zhang S, Lin M, Fan H, Jian Z, You R, Liu F, Wu M, Xu W, Tang H, Hou Y, Tan L. Primary Tumour Burden Score: A Novel Staging Parameter for Oesophageal Squamous Cell Carcinoma after Neoadjuvant Chemoradiotherapy. Eur J Cardiothorac Surg. 2025 Sep 2;67(9):ezaf254. doi: 10.1093/ejcts/ezaf254.

Reference Type DERIVED
PMID: 40758472 (View on PubMed)

Other Identifiers

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CMISG1708

Identifier Type: -

Identifier Source: org_study_id

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