Esophageal CancerNCT05617352
The Impact of Two-field or Three-field Lymphadenectomy on Overall Survival in Middle and Lower Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study
An observational study of Esophageal Cancer, run by Yongtao Han at 1 site in China.
Trial summary
To clarify the effect of Two-field or Three-field Lymphadenectomy on the survival of esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophageal Cancer
- How many people
- 1,659 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 10 Oct 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with esophageal cancer and need surgical treatment.
Who may be able to join
- 1. Men and women aged 18-85 years
- 2. Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
- 3. Staging PT1b-4A, N0-3, M0 AJCC eighth edition
- 4. Excluding lymph node dissection < 15, (meeting the guideline criteria)
- 5. The tumor located in the lower middle thoracic.
Who cannot join
- 1. Patients with a history of previous thoracic and abdominal surgery that may affect lymphatic reflux
- 2. Patients with distant metastasis confirmed by imaging
- 3. Patients with obvious surgical contraindications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Two-field or Three-field Lymphadenectomy on Overall Survival in Middle and Lower Thoracic Esophageal Squamous Cell Carcinoma: A Single Center Retrospective Analysis
To clarify the effect of Two-field or Three-field Lymphadenectomy on the survival of esophageal squamous cell carcinoma.
- Conditions
- Esophageal Cancer
- Being tested
- Since the data were collected retrospectively, there were no interventions
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Since the data were collected retrospectively, there were no interventionsDiagnostic test
Since the data were collected retrospectively, there were no interventions
| Study group | Role | What they receive |
|---|---|---|
| 2F Group | Patients with Two-field Lymphadenectomy Receives: Diagnostic Test: Since the data were collected retrospectively, there were no interventions | |
| 3F Group | Patients with Three-field Lymphadenectomy Receives: Diagnostic Test: Since the data were collected retrospectively, there were no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of lymph nodes
Surgical data were retrospectively collected
Measured: 2010.1.1-2017.12.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 May 2022
- Primary completion1 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yongtao Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongtao Han, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617352
- Sponsor's protocol ID
- SCCH-TS2204
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are willing to share data, analytic methods, and study materials related to this article with other researchers. Provided that all of the above will not be used for commercial or profit purposes. Other researchers can contact the corresponding author of this article by email and indicate the required research materials and purpose. We will be glad to provide relevant materials for this study after approval and discussion.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Two-field or Three-field Lymphadenectomy on Overall Survival in Middle and Lower Thoracic Esophageal Squamous Cell Carcinoma: A Single Center Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05617352
- Acronym / sponsor ID
- SCCH-TS2204
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,659 participants (actual)
- Lead sponsor
- Yongtao HanUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 15 Nov 2022 (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.
To clarify the effect of Two-field or Three-field Lymphadenectomy on the survival of esophageal squamous cell carcinoma.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2F Group | – | Diagnostic Test: Since the data were collected retrospectively, there were no interventionsPatients with Two-field Lymphadenectomy |
| 3F Group | – | Diagnostic Test: Since the data were collected retrospectively, there were no interventionsPatients with Three-field Lymphadenectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal cancer and need surgical treatment.
Key inclusion criteria (5 listed)
- 1. Men and women aged 18-85 years
- 2. Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
- 3. Staging PT1b-4A, N0-3, M0 AJCC eighth edition
- 4. Excluding lymph node dissection < 15, (meeting the guideline criteria)
- 5. The tumor located in the lower middle thoracic.
Key exclusion criteria (3 listed)
- 1. Patients with a history of previous thoracic and abdominal surgery that may affect lymphatic reflux
- 2. Patients with distant metastasis confirmed by imaging
- 3. Patients with obvious surgical contraindications.
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 |
|---|---|---|
| Since the data were collected retrospectively, there were no interventionsSince the data were collected retrospectively, there were no interventions | Diagnostic test | 2F Group, 3F Group |
Primary outcome
The number of lymph nodes
Time frame: 2010.1.1-2017.12.30
Surgical data were retrospectively collected
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 21 Nov 2022.
- Individual participant dataSharing planned: Undecided. We are willing to share data, analytic methods, and study materials related to this article with other researchers. Provided that all of the above will not be used for commercial or profit purposes. Other researchers can contact the corresponding author of this article by email and indicate the required research materials and purpose. We will be glad to provide relevant materials for this study after approval and discussion.
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
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 Cancer, run by Yongtao Han 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 5 inclusion and 3 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 21 Nov 2022. 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?
The number of lymph nodes (time frame: 2010.1.1-2017.12.30). 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 21 Nov 2022.