Primary Tumor Burden Score:A Novel Staging Parameter for ESCC After nCRT
Primary Tumor Burden Score: A Novel Staging Parameter Superior to ypT-category for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy
1 other identifier
observational
187
0 countries
N/A
Brief Summary
In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2023
CompletedFirst Submitted
Initial submission to the registry
March 29, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedMay 3, 2023
April 1, 2023
11.5 years
March 29, 2023
April 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Five-year survival of patients
The survival of the patients was recorded by follow-up for five years after surgery.
From surgery to the end of follow-up(at least 5 years later)
Study Arms (2)
Training cohort
Training cohort will be used to find the best calculation and cut-off values for PTBS in ESCC after nCRT.
Validation cohort
The study's conclusion will be verified in Zhongshan Hospital Xiamen branch.
Interventions
Eligibility Criteria
Patients with ESCC undergoing nCRT at the Department of Thoracic Surgery, Zhongshan Hospital of Fudan University (training cohort), and the Department of Thoracic Surgery, Zhongshan Hospital Xiamen Branch (validation cohort), between January 2010 and February 2019 were reviewed. The inclusion criteria were (I) thoracic ESCC; (II) McKeown or Ivor-Lewis transthoracic approach; (III) locally advanced resectable tumor with cT3-4aNany staging treated with nCRT; (IV) no history of concomitant or prior malignancy.
You may qualify if:
- \- Neoadjuvant chemoradiotherapy and surgical resection of esophageal squamous cell carcinoma
You may not qualify if:
- Patients receiving neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma without surgical resection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
- Shanghai Zhongshan Hospitalcollaborator
Related Publications (1)
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.
PMID: 40758472DERIVED
Biospecimen
Patients' pathological sections
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Physician
Study Record Dates
First Submitted
March 29, 2023
First Posted
May 3, 2023
Study Start
May 21, 2010
Primary Completion
December 1, 2021
Study Completion
March 15, 2023
Last Updated
May 3, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share