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CompletedNCT05839002Updated May 3, 2023

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

An observational study in Neoplasm, Esophagus and Neoplasm, Squamous Cell, sponsored by Fudan University. Completed. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Fudan University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
187
Ages
40 Years to 79 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 27 studies in Esophageal Neoplasms by Fudan University — 13 open to participants now, 16 under way, 3 of them phase 3. Esophageal Neoplasms · Fudan University.

Enrollment
7th of 10
187 · median 200
Started
2010
with 2 others
Observational
10 of 27
7 open now
Registered
16th of 27
by date

Among the 27 studies in Esophageal Neoplasms by Fudan University, this one is the 7th largest by enrollment of the 10 observational ones that give a count, is one of 3 that started in 2010, is one of 10 observational ones, and was the 16th registered.

Esophageal Neoplasms

1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.

This study's enrollment of 187 is close to the median of 200 across 432 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Open to participants now

13 of the 27 studies in Esophageal Neoplasms by Fudan University are open now, in 1 country. Each count lists the studies.

All 13 open studies →

Where they have run

Who these studies take

Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.

This study: 40 Years to 79 Years · all sexes · no healthy volunteers.

The full table on the hub →
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02

Study summary

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

Read the 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.

03

Conditions studied

  • Neoplasm, Esophagus
  • Neoplasm, Squamous Cell
04

Who can participate

Ages eligible
40 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • chemoradiotherapy and surgical resection of esophageal squamous cell carcinoma

Exclusion criteria

Exclusion Criteria:

  • Patients receiving chemoradiotherapy for esophageal squamous cell carcinoma without surgical resection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
187 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Training cohort

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

    Procedure: nCRT

  • Validation cohort

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

    Procedure: nCRT

Interventions

  • ProcedurenCRT

    ESCC patients that recieved surgery and nCRT.

06

What researchers measure

Primary outcomes

  1. Five-year survival of patients

    The survival of the patients was recorded by follow-up for five years after surgery.

    Time frame: From surgery to the end of follow-up(at least 5 years later)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2010 to primary completion in Dec 2021, 138 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2023
First posted
May 3, 2023
StartActual
May 21, 2010
Primary completionActual
Dec 1, 2021
CompletionActual
Mar 15, 2023
Last update
May 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05839002
Lead sponsor
Fudan University
Responsible party
Xu Huang (Resident Physician, Fudan University) — Principal investigator
First posted
May 3, 2023
Start date
May 21, 2010
Primary completion
Dec 1, 2021
Completion
Mar 15, 2023
Last update
May 3, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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