Esophageal CancerECPLNMvsSLNMNCT06165094
Effect of Cervical Paraesophageal Lymph Node Metastasis Versus Supraclavicular Lymph Node Metastasis on the Overall Survival of Patients With Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study
An observational study of Esophageal Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
The goal of this observational study is to learn about in health conditions of ESCC. The main question[s] it aims to answer are: •Lymph node metastasis(LNM) in cervical paraesophageal or supraclavicular which influence OS more. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2009to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Demographic and pathologic data, including gender, age, pathological T stage, pathological N stage, 8th tumor-node-metastasis (TNM) stage, tumor location, tumor grade, lymphovascular invasion, perineural invasion, LNM, cervical paraesophageal LNM, supraclavicular LNM, and radical resection, were collected from the Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management (SCH-ECCM) database.
The inclusion criteria were as follows:
- patients who had undergone esophagectomy and
- patients who exhibited LNM in the supraclavicular region.
The exclusion criteria:
- tumor location outside the thoracic region,
- pathological examination results confirming the presence of non-squamous cell carcinoma, - patients with both cervical paraesophageal LNM and supraclavicular LNM, or
- those with missing required data
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn about in health conditions of ESCC. The main question[s] it aims to answer are:
•Lymph node metastasis(LNM) in cervical paraesophageal or supraclavicular which influence OS more.
Participants will describe the main status quo after surgery
Researchers will compare Lymph node metastasis(LNM) in cervical paraesophageal and supraclavicular to see if dead.
Read the detailed description
Demographic and pathologic data, including gender, age, pathological T stage, pathological N stage, 8th tumor-node-metastasis (TNM) stage, tumor location, tumor grade, lymphovascular invasion, perineural invasion, LNM, cervical paraesophageal LNM, supraclavicular LNM, and radical resection, were collected from the Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management (SCH-ECCM) database.
- Conditions
- Esophageal Cancer
- Keywords
- oesophageal squamous cell carcinoma; cervical paraesophageal lymph node metastasis; supraclavicular lymph node metastasis; lymphadenectomy; esophagectomy
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with supraclavicular LNM | There was no intervention(s) in any group | |
| Diagnosed with paraesophageal LNM | There was no intervention(s) in any group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
OS was calculated from the month and year of surgery until the time of death or the last follow-up in March 2021.
Measured: 2009.01.01-2017.12.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jan 2009
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongtao Han, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165094
- Sponsor's protocol ID
- SCCH-TS2206
- Other IDs
- 2023YFQ0056
- Acronym
- ECPLNMvsSLNM
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Paraesophageal Lymph Node Metastasis Versus Supraclavicular Lymph Node Metastasis on the Overall Survival of Patients With Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study
- ClinicalTrials.gov ID
- NCT06165094
- Acronym / sponsor ID
- ECPLNMvsSLNM / SCCH-TS2206
- Conditions
- Esophageal Cancer
- Keywords
- oesophageal squamous cell carcinoma; cervical paraesophageal lymph node metastasis; supraclavicular lymph node metastasis; lymphadenectomy; esophagectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 11 Dec 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.
The goal of this observational study is to learn about in health conditions of ESCC. The main question[s] it aims to answer are:
•Lymph node metastasis(LNM) in cervical paraesophageal or supraclavicular which influence OS more.
Participants will describe the main status quo after surgery
Researchers will compare Lymph node metastasis(LNM) in cervical paraesophageal and supraclavicular to see if dead.
Detailed description
Demographic and pathologic data, including gender, age, pathological T stage, pathological N stage, 8th tumor-node-metastasis (TNM) stage, tumor location, tumor grade, lymphovascular invasion, perineural invasion, LNM, cervical paraesophageal LNM, supraclavicular LNM, and radical resection, were collected from the Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management (SCH-ECCM) database.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with supraclavicular LNM | – | –There was no intervention(s) in any group |
| Diagnosed with paraesophageal LNM | – | –There was no intervention(s) in any group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Demographic and pathologic data, including gender, age, pathological T stage, pathological N stage, 8th tumor-node-metastasis (TNM) stage, tumor location, tumor grade, lymphovascular invasion, perineural invasion, LNM, cervical paraesophageal LNM, supraclavicular LNM, and radical resection, were collected from the Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management (SCH-ECCM) database.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 2009.01.01-2017.12.30
OS was calculated from the month and year of surgery until the time of death or the last follow-up in March 2021.
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 11 Dec 2023.
- 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.
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 Sichuan Cancer Hospital and Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. 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?
Overall survival (time frame: 2009.01.01-2017.12.30). 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 11 Dec 2023.