the Records of Esophageal CancerNCT05570487
RESECTED LYMPH NODES AND SURVIVAL OF PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA: AN OBSERVATIONAL STUDY
An observational study of the Records of Esophageal Cancer, run by Yongtao Han at 1 site in China.
Trial summary
To clarify the effect of the number of lymph node dissection and the number of stations on survival Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- the Records of Esophageal Cancer
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 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 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
- Men and women aged 18-85;
- Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
- Staging PT1-4A, N0-3, M0 AJCC eighth edition;
- Excluding lymph node dissection < 15,(meeting the guideline criteria)
Who cannot join
- Patients with a history of previous thoracic and abdominal surgery that may affect lymphatic reflux
- Patients with distant metastasis confirmed by imaging;
- Patients with obvious surgical contraindications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Yongtao Han, +8618702870755, doc.leng@uestc.edu.cn
About this study
Official title: Increasing the Number of Resected Lymph Nodes Improves Overall Survival of Patients With Esophageal Squamous Cell Carcinoma With Positive Lymph Nodes: a Retrospective Analysis of 1656 Cases at a Single Cancer Center
To clarify the effect of the number of lymph node dissection and the number of stations on survival
- Conditions
- the Records of Esophageal Cancer
- Being tested
- Since the data were collected retrospectively, there were no interventions
- Keywords
- esophageal cancer, lympha nodes
- 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 |
|---|---|---|
| N0A Group | patients with negative lymph nodes and resected lymph nodes less than 15 Receives: Diagnostic Test: Since the data were collected retrospectively, there were no interventions | |
| N0B Group | patients with negative lymph nodes and resected lymph nodes no less than 15 Receives: Diagnostic Test: Since the data were collected retrospectively, there were no interventions | |
| N+A Group | patients with positive lymph nodes and resected lymph nodes less than 15 Receives: Diagnostic Test: Since the data were collected retrospectively, there were no interventions | |
| N+B Group | patients with positive lymph nodes and resected lymph nodes no less than 15 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 posted6 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for the Records of 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (estimated)
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
- NCT05570487
- Sponsor's protocol ID
- SichuanCHRIA
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 25 Oct 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.
Publications
Li K, Leng X, Peng L. Resected lymph nodes and survival of patients with esophageal squamous cell carcinoma in pT2 and pT3. Int J Surg. 2024 Mar 1;110(3):1879-1881. doi: 10.1097/JS9.0000000000001023. No abstract available.
PubMed 38116658Li K, Leng X, He W, Du K, Li C, Liu K, Wang C, Liu G, Li Z, Jiang L, Li K, Zhou Q, Li J, Luo X, Nie X, Lu S, Li H, Fang Q, Xiao W, Han Y, Peng L. Resected lymph nodes and survival of patients with esophageal squamous cell carcinoma: an observational study. Int J Surg. 2023 Jul 1;109(7):2001-2009. doi: 10.1097/JS9.0000000000000436.
PubMed 37222685
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Number of Resected Lymph Nodes Improves Overall Survival of Patients With Esophageal Squamous Cell Carcinoma With Positive Lymph Nodes: a Retrospective Analysis of 1656 Cases at a Single Cancer Center
- ClinicalTrials.gov ID
- NCT05570487
- Acronym / sponsor ID
- SichuanCHRIA
- Conditions
- the Records of Esophageal Cancer
- Keywords
- esophageal cancer, lympha nodes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Yongtao HanUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 6 Oct 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 the number of lymph node dissection and the number of stations on survival
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| N0A Group | – | Diagnostic Test: Since the data were collected retrospectively, there were no interventionspatients with negative lymph nodes and resected lymph nodes less than 15 |
| N0B Group | – | Diagnostic Test: Since the data were collected retrospectively, there were no interventionspatients with negative lymph nodes and resected lymph nodes no less than 15 |
| N+A Group | – | Diagnostic Test: Since the data were collected retrospectively, there were no interventionspatients with positive lymph nodes and resected lymph nodes less than 15 |
| N+B Group | – | Diagnostic Test: Since the data were collected retrospectively, there were no interventionspatients with positive lymph nodes and resected lymph nodes no less than 15 |
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 (4 listed)
- Men and women aged 18-85;
- Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
- Staging PT1-4A, N0-3, M0 AJCC eighth edition;
- Excluding lymph node dissection < 15,(meeting the guideline criteria)
Key exclusion criteria (3 listed)
- Patients with a history of previous thoracic and abdominal surgery that may affect lymphatic reflux
- Patients with distant metastasis confirmed by imaging;
- 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 | N+A Group, N+B Group, N0A Group, N0B Group |
Primary outcome
The number of lymph nodes
Time frame: 2010.1.1-2017.12.30
Surgical data were retrospectively collected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 38116658Li K, Leng X, Peng L. Resected lymph nodes and survival of patients with esophageal squamous cell carcinoma in pT2 and pT3. Int J Surg. 2024 Mar 1;110(3):1879-1881. doi: 10.1097/JS9.0000000000001023. No abstract available.
- Derived from this study: PubMed 37222685Li K, Leng X, He W, Du K, Li C, Liu K, Wang C, Liu G, Li Z, Jiang L, Li K, Zhou Q, Li J, Luo X, Nie X, Lu S, Li H, Fang Q, Xiao W, Han Y, Peng L. Resected lymph nodes and survival of patients with esophageal squamous cell carcinoma: an observational study. Int J Surg. 2023 Jul 1;109(7):2001-2009. doi: 10.1097/JS9.0000000000000436.
- 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.
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.
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 the Records 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 4 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: status not confirmed, as of the sponsor's last update on 25 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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?
On the ClinicalTrials.gov record for NCT05570487, which also lists 2 linked publications.
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 25 Oct 2022.