Esophageal CancerNCT05604664
Clinical Value and Efficacy Index of Lymphadenectomy for Thoracic Escc
An observational study of Esophageal Cancer, run by Yongtao Han at 1 site in China.
Trial summary
The goal of this observational study is to to clarify the focus of lymph node dissection during esophagectomy.. The main question[s] it aims to answer is: provide a basis for accurate staging and the relationship between OS and lymph node dissection Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- How many people
- 1,727 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: (1) Pathologic findings proved esophageal cancer (8th AJCC/UICC stage T1b-4aN0-3M0). (2) underwent esophagecomy (two-field or three-field LN dissection). (3)The primary tumor was thoracic esophageal cancer.
Who may be able to join
- Pathologic findings proved ESCC (8th AJCC/UICC stage T1b-4aN0-3M0)
- Underwent esophagecomy (two-field or three-field LN dissection)
- The primary tumor was thoracic ESCC
Who cannot join
- Located outside the thoracic
- Patients underwent salvage or R1/R2 esophagecomy
- The number of resected lymph nodes (RLNs) less than 15
- With neoadjuvant therapy(NT) or salvage chemoradiotherapy(SCRT)
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
About this study
Official title: Clinical Value and Efficacy Index of Lymphadenectomy for Thoracic Esophageal Squamous Cell Carcinoma
The goal of this observational study is to to clarify the focus of lymph node dissection during esophagectomy.. The main question[s] it aims to answer is:
- provide a basis for accurate staging and the relationship between OS and lymph node dissection
- Conditions
- Esophageal Cancer
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year survival rate of lymph nodes metastases (%) in patients
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 posted3 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
- 1,727 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
- NCT05604664
- Sponsor's protocol ID
- SCCH-TS2203
- Status last verified
- Nov 2022
- First submitted
- 29 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value and Efficacy Index of Lymphadenectomy for Thoracic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05604664
- Acronym / sponsor ID
- SCCH-TS2203
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,727 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
- 3 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.
The goal of this observational study is to to clarify the focus of lymph node dissection during esophagectomy.. The main question[s] it aims to answer is:
- provide a basis for accurate staging and the relationship between OS and lymph node dissection
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- (1) Pathologic findings proved esophageal cancer (8th AJCC/UICC stage T1b-4aN0-3M0). (2) underwent esophagecomy (two-field or three-field LN dissection). (3)The primary tumor was thoracic esophageal cancer.
Key inclusion criteria (3 listed)
- Pathologic findings proved ESCC (8th AJCC/UICC stage T1b-4aN0-3M0)
- Underwent esophagecomy (two-field or three-field LN dissection)
- The primary tumor was thoracic ESCC
Key exclusion criteria (4 listed)
- Located outside the thoracic
- Patients underwent salvage or R1/R2 esophagecomy
- The number of resected lymph nodes (RLNs) less than 15
- With neoadjuvant therapy(NT) or salvage chemoradiotherapy(SCRT)
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
5-year survival rate of lymph nodes metastases (%) in patients
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 4 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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 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 3 inclusion and 4 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 4 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?
5-year survival rate of lymph nodes metastases (%) in patients (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 4 Nov 2022.