National Cancer Center/Cancer HospitalNCT05526456
Mapping of Lymph Node Metastasis and Survival For pN+ Superficial Esophageal Squamous Cell Carcinoma
An observational study of National Cancer Center/Cancer Hospital, run by National Cancer Center, China.
Trial summary
With the deeper tumor invasion, the higher LNM rate beside the bilateral recurrent laryngeal nerves(RLN) was. Read more about this study
- Who is it for?
- Ages 44 to 73 years
- Conditions the study is for
- National Cancer Center/Cancer Hospital
- What is being tested?
- Esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2012to 15 May 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 44 to 73 years
- All sexes
- Adult, Older adult
Study population: Among the 207 patients, 22 were in the T1a stage, whereas 185 were in the T1b stage. The invasion depth was EP in 2, LPM in 1, MM in 17, SM1 in 37, SM2 in 39 and SM3 in 97 patients
Who may be able to join
- Our predefined search strategy identified pT1N+ ESCC cases without preoperative treatment, between February 2012 and April 2022.
Who cannot join
- The patients were excluded because they were (1)less than 10 lymph nodes removed; (2) lacked specific sites of LNM; or (3) incomplete follow-up information.
About this study
Official title: Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
With the deeper tumor invasion, the higher LNM rate beside the bilateral recurrent laryngeal nerves(RLN) was.
- Conditions
- National Cancer Center/Cancer Hospital
- Being tested
- Esophagectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
McKeown, Ivor-Lewis, and Sweet procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
LNM rates of the 207 thoracic T1N+ ESCC patients.
Measured: 2012.2-2022.4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Feb 2012
- Primary completion30 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for National Cancer Center/Cancer HospitalStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yin Li, National Cancer Center, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526456
- Sponsor's protocol ID
- 20/388-2584
- Status last verified
- Aug 2022
- First submitted
- 31 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- ClinicalTrials.gov ID
- NCT05526456
- Acronym / sponsor ID
- 20/388-2584
- Conditions
- National Cancer Center/Cancer Hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- National Cancer Center, ChinaUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 2 Sep 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.
With the deeper tumor invasion, the higher LNM rate beside the bilateral recurrent laryngeal nerves(RLN) was.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 44 to 73 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Among the 207 patients, 22 were in the T1a stage, whereas 185 were in the T1b stage. The invasion depth was EP in 2, LPM in 1, MM in 17, SM1 in 37, SM2 in 39 and SM3 in 97 patients
Key inclusion criteria (1 listed)
- Our predefined search strategy identified pT1N+ ESCC cases without preoperative treatment, between February 2012 and April 2022.
Key exclusion criteria (1 listed)
- The patients were excluded because they were (1)less than 10 lymph nodes removed; (2) lacked specific sites of LNM; or (3) incomplete follow-up information.
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 |
|---|---|---|
| EsophagectomyMcKeown, Ivor-Lewis, and Sweet procedure | Procedure or surgery | – |
Primary outcome
LNM rates of the 207 thoracic T1N+ ESCC patients.
Time frame: 2012.2-2022.4
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 2 Sep 2022.
Related trials for National Cancer Center/Cancer Hospital
RecruitingPhase 2
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
Salivary Gland Carcinoma, Precision Therapy
Not yet recruiting
A Study on the Efficacy and Safety of Telitacicept in the Treatment of Children Ocular Myasthenia Gravis
Effectiveness
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.
Questions about this trial
What is this clinical trial studying?
An observational study of National Cancer Center/Cancer Hospital, run by National Cancer Center, 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 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
LNM rates of the 207 thoracic T1N+ ESCC patients. (time frame: 2012.2-2022.4). 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 2 Sep 2022.