Esophageal Squamous Cell CarcinomaNCT06241066
The Prognostic Value of Tertiary Lymphatic Structure in Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Retrospective analysis of the presence and maturity of tertiary lymphoid structures in pathological sections of patients with esophageal squamous cell carcinoma after surgical treatment. Pay attention to the overall survival and disease free survival of these esophageal squamous cell carcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- no-Intervention
- How many people
- 359 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Oct 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients pathologically confirmed esophageal squamous cell carcinoma(ESCC) who underwent complete surgical resection at Tianjin Medical University Cancer Hospital between 2014 and 2021
Who may be able to join
- 1. Pathologically diagnosed as esophageal squamous cell carcinoma; 2. Surgery for esophageal cancer; 3. Complete medical records;
Who cannot join
- Patients with a previous history of malignant tumor
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective analysis of the presence and maturity of tertiary lymphoid structures in pathological sections of patients with esophageal squamous cell carcinoma after surgical treatment. Pay attention to the overall survival and disease free survival of these esophageal squamous cell carcinoma patients.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- no-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.
no-InterventionOther
no-Intervention
| Study group | Role | What they receive |
|---|---|---|
| Surgery alone group | Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection without any prior treatment are included in this group. These patients had not been diagnosed with any other cancer. Finally, 96 patients were included. Receives: Other: no-Intervention | |
| Neoadjuvant chemotherapy group | Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 89 patients were included. Receives: Other: no-Intervention | |
| Neoadjuvant chemotherapy combined with immunotherapy group | Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy combined with immunotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 81 patients were included. Receives: Other: no-Intervention | |
| Neoadjuvant chemotherapy combined with radiotherapy group | Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy combined with radiotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 93 patients were included. Receives: Other: no-Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall Survival
Measured: The time from treatment to death or last follow-up, assessed up to 100 months.
DFS
Disease-free Survival
Measured: The time from treatment to the first recurrence or last follow-up, assessed up to 100 months.
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 start1 Jan 2014
- Primary completion31 Oct 2023
- Study completion31 Oct 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
- 359 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wencheng Zhang, M.D., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241066
- Sponsor's protocol ID
- bc2023192
- Status last verified
- Dec 2023
- First submitted
- 25 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- The Prognostic Value of Tertiary Lymphatic Structure in Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06241066
- Acronym / sponsor ID
- bc2023192
- Conditions
- Esophageal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 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.
Retrospective analysis of the presence and maturity of tertiary lymphoid structures in pathological sections of patients with esophageal squamous cell carcinoma after surgical treatment. Pay attention to the overall survival and disease free survival of these esophageal squamous cell carcinoma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Surgery alone group | – | Other: no-InterventionPatients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection without any prior treatment are included in this group. These patients had not been diagnosed with any other cancer. Finally, 96 patients were included. |
| Neoadjuvant chemotherapy group | – | Other: no-InterventionPatients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 89 patients were included. |
| Neoadjuvant chemotherapy combined with immunotherapy group | – | Other: no-InterventionPatients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy combined with immunotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 81 patients were included. |
| Neoadjuvant chemotherapy combined with radiotherapy group | – | Other: no-InterventionPatients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy combined with radiotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 93 patients were included. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients pathologically confirmed esophageal squamous cell carcinoma(ESCC) who underwent complete surgical resection at Tianjin Medical University Cancer Hospital between 2014 and 2021
Key inclusion criteria (1 listed)
- 1. Pathologically diagnosed as esophageal squamous cell carcinoma; 2. Surgery for esophageal cancer; 3. Complete medical records;
Key exclusion criteria (1 listed)
- Patients with a previous history of malignant tumor
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 |
|---|---|---|
| no-Interventionno-Intervention | Other | Neoadjuvant chemotherapy combined with immunotherapy group, Neoadjuvant chemotherapy combined with radiotherapy group, Neoadjuvant chemotherapy group, Surgery alone group |
Primary outcome
OS
Time frame: The time from treatment to death or last follow-up, assessed up to 100 months.
Overall Survival
DFS
Time frame: The time from treatment to the first recurrence or last follow-up, assessed up to 100 months.
Disease-free Survival
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.
- 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.
Wencheng Zhang, M.D. principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
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 at 1 site in China.
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.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
OS (time frame: The time from treatment to death or last follow-up, assessed up to 100 months.). The study lists 2 primary outcomes in all. 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.