Neoplasm, EsophagusNCT05839002
Primary Tumor Burden Score:A Novel Staging Parameter for ESCC After nCRT
An observational study of Neoplasm, Esophagus and Neoplasm, Squamous Cell, run by Fudan University.
Trial summary
In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Neoplasm, Esophagus, Neoplasm, Squamous Cell
- What is being tested?
- nCRT
- Type of treatment
- Surgery or procedure
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2010to 15 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Neoadjuvant chemoradiotherapy and surgical resection of esophageal squamous cell carcinoma
Who cannot join
- Patients receiving neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma without surgical resection
About this study
Official title: Primary Tumor Burden Score: A Novel Staging Parameter Superior to ypT-category for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy
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.
- Conditions
- Neoplasm, Esophagus, Neoplasm, Squamous Cell
- Being tested
- nCRT
- Medical subject headings
- Esophageal Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCRTProcedure or surgery
ESCC patients that recieved surgery and nCRT.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Training cohort will be used to find the best calculation and cut-off values for PTBS in ESCC after nCRT. Receives: Procedure: nCRT | |
| Validation cohort | The study's conclusion will be verified in Zhongshan Hospital Xiamen branch. Receives: Procedure: nCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-year survival of patients
The survival of the patients was recorded by follow-up for five years after surgery.
Measured: From surgery to the end of follow-up(at least 5 years later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start21 May 2010
- Primary completion1 Dec 2021
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm, EsophagusStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Xu Huang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839002
- Sponsor's protocol ID
- CMISG1708
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40758472
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Tumor Burden Score: A Novel Staging Parameter Superior to ypT-category for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05839002
- Acronym / sponsor ID
- CMISG1708
- Conditions
- Neoplasm, Esophagus, Neoplasm, Squamous Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 21 May 2010 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS).
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Procedure: nCRTTraining cohort will be used to find the best calculation and cut-off values for PTBS in ESCC after nCRT. |
| Validation cohort | – | Procedure: nCRTThe study's conclusion will be verified in Zhongshan Hospital Xiamen branch. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Neoadjuvant chemoradiotherapy and surgical resection of esophageal squamous cell carcinoma
Key exclusion criteria (1 listed)
- Patients receiving neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma without surgical resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nCRTESCC patients that recieved surgery and nCRT. | Procedure or surgery | Training cohort, Validation cohort |
Primary outcome
Five-year survival of patients
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 40758472Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm, Esophagus and Neoplasm, Squamous Cell, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-year survival of patients (time frame: From surgery to the end of follow-up(at least 5 years later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.