Esophageal Squamous Cell CarcinomaNCT06241079
Multi-institutional Analysis of Survival and Recurrence Patterns of Different Pathological Regression Types After Neoadjuvant Chemoradiotherapy or Radiotherapy for Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
The goal of this multicenter retrospective cohort study is to evaluate the impact of different pathological regression types on survival and recurrence patterns, with a particular focus on ypT0N+ patients in patients with esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- non-intervention
- How many people
- 582 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2003to 1 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with esophageal squamous cell carcinoma (ESCC) who received NCRT or neoadjuvant radiotherapy (NRT) followed by esophagectomy from 2003 to 2022
Who may be able to join
- histologically confirmed potentially resectable ESCC, clinical stage T1-4N0-1M0 (stage I-III) according to the American Joint Committee on Cancer 6th edition staging criteria.
Who cannot join
- incomplete surgical resection, two-dimensional radiotherapy, and incomplete clinical data.
About this study
The goal of this multicenter retrospective cohort study is to evaluate the impact of different pathological regression types on survival and recurrence patterns, with a particular focus on ypT0N+ patients in patients with esophageal squamous cell carcinoma. The main questions it aims to answer are the survival and recurrence patterns among the different pathological regression types in patients with esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- non-intervention
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionOther
non-intervention
| Study group | Role | What they receive |
|---|---|---|
| ypT0N0 | Not described Receives: Other: non-intervention | |
| ypT0N+ | Not described Receives: Other: non-intervention | |
| ypT+N0 | Not described Receives: Other: non-intervention | |
| ypT+N+ | Not described Receives: Other: non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
the time from the date of surgery to death or last follow-up (2023.01.31)
Measured: From date of surgery until the date of death from any cause or last follow-up, assessed up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start31 Mar 2003
- Primary completion28 Apr 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Sichuan Cancer Hospital and Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241079
- Sponsor's protocol ID
- bc2023183
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-institutional Analysis of Survival and Recurrence Patterns of Different Pathological Regression Types After Neoadjuvant Chemoradiotherapy or Radiotherapy for Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06241079
- Acronym / sponsor ID
- bc2023183
- Conditions
- Esophageal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Sichuan Cancer Hospital and Research Institute
- Study start
- 31 Mar 2003 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 5 Feb 2024 (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.
The goal of this multicenter retrospective cohort study is to evaluate the impact of different pathological regression types on survival and recurrence patterns, with a particular focus on ypT0N+ patients in patients with esophageal squamous cell carcinoma. The main questions it aims to answer are the survival and recurrence patterns among the different pathological regression types in patients with esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ypT0N0 | – | Other: non-intervention |
| ypT0N+ | – | Other: non-intervention |
| ypT+N0 | – | Other: non-intervention |
| ypT+N+ | – | Other: non-intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with esophageal squamous cell carcinoma (ESCC) who received NCRT or neoadjuvant radiotherapy (NRT) followed by esophagectomy from 2003 to 2022
Key inclusion criteria (1 listed)
- histologically confirmed potentially resectable ESCC, clinical stage T1-4N0-1M0 (stage I-III) according to the American Joint Committee on Cancer 6th edition staging criteria.
Key exclusion criteria (1 listed)
- incomplete surgical resection, two-dimensional radiotherapy, and incomplete clinical data.
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 |
|---|---|---|
| non-interventionnon-intervention | Other | ypT+N+, ypT+N0, ypT0N+, ypT0N0 |
Primary outcome
Overall survival
Time frame: From date of surgery until the date of death from any cause or last follow-up, assessed up to 10 years.
the time from the date of surgery to death or last follow-up (2023.01.31)
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 5 Feb 2024.
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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 Esophageal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
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 5 Feb 2024. 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?
Overall survival (time frame: From date of surgery until the date of death from any cause or last follow-up, assessed up to 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2024.