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

Sponsor

Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT05839002

Collaborator

Shanghai Zhongshan Hospital (Other)

187

Enrollment

153.8

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neoplasm, Esophagus Neoplasm, Squamous Cell	Procedure: nCRT

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

187 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Primary Tumor Burden Score: A Novel Staging Parameter Superior to ypT-category for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy

Actual Study Start Date :

May 21, 2010

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Training cohort Training cohort will be used to find the best calculation and cut-off values for PTBS in ESCC after nCRT.	Procedure: nCRT ESCC patients that recieved surgery and nCRT.
Validation cohort The study's conclusion will be verified in Zhongshan Hospital Xiamen branch.	Procedure: nCRT ESCC patients that recieved surgery and nCRT.

Arm

Intervention/Treatment

Training cohort

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

Procedure: nCRT

ESCC patients that recieved surgery and nCRT.

Validation cohort

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

Procedure: nCRT

ESCC patients that recieved surgery and nCRT.

Outcome Measures

Primary Outcome Measures

Five-year survival of patients [From surgery to the end of follow-up(at least 5 years later)]
The survival of the patients was recorded by follow-up for five years after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fudan University
Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xu Huang, Resident Physician, Fudan University

ClinicalTrials.gov Identifier:

NCT05839002

Other Study ID Numbers:

CMISG1708

First Posted:

May 3, 2023

Last Update Posted:

May 3, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Neoplasms, Squamous Cell

Esophageal Neoplasms

Study Results

No Results Posted as of May 3, 2023