Outcomes of Smoker and Drinker After EsophagectomyOSinECNCT06269341
Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy
An observational study of Outcomes of Smoker and Drinker After Esophagectomy, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Outcomes of Smoker and Drinker After Esophagectomy
- How many people
- 2,957 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2010to 30 Aug 2024
- 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
Who may be able to join
- patients with esophageal cancer
Who cannot join
- pathology confirmed a non-squamous cell carcinoma, (2) the tumor was located outside of the thoracic region, (3) R1/R2 resection was performed indicating incomplete tumor removal, (4) evidence of distant tumor metastasis was observed, (5) they underwent preoperative neoadjuvant therapy, (6) pTis/T1a stage (7) Missing data.
Trial locations and contacts
1 site in 1 country.
Xuefeng Leng contact
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
Lin Peng, M.D., +8618908190013, penglinms@126.com
Wenwu He, M.D., +8613350055340, wenwu_he@126.com
About this study
Official title: Long-term Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy
Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank
- Being tested
- No intervention
- Keywords
- survival, esophgeal cancer, smoker, drinker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| high-risk | Smoker and Drinker with Esophageal Squamous Cell Carcinoma after Esophagectomy Receives: Other: No intervention | |
| low-risk | Non-Smoker and Non-Drinker with Esophageal Squamous Cell Carcinoma after Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall Survival was calculated from the month and year of surgery to the time of death or last follow-up in April 2024
Measured: April 2022-April 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Feb 2010
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcomes of Smoker and Drinker After EsophagectomyStudies 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
- 2,957 participants (estimated)
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
- NCT06269341
- Sponsor's protocol ID
- SCCH-TS2208
- Acronym
- OSinEC
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 21 Feb 2024
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy
- ClinicalTrials.gov ID
- NCT06269341
- Acronym / sponsor ID
- OSinEC / SCCH-TS2208
- Keywords
- survival, esophgeal cancer, smoker, drinker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,957 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 21 Feb 2024 (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.
Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-risk | – | Other: No interventionSmoker and Drinker with Esophageal Squamous Cell Carcinoma after Esophagectomy |
| low-risk | – | –Non-Smoker and Non-Drinker with Esophageal Squamous Cell Carcinoma after Esophagectomy |
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
Key inclusion criteria (1 listed)
- patients with esophageal cancer
Key exclusion criteria (1 listed)
- pathology confirmed a non-squamous cell carcinoma, (2) the tumor was located outside of the thoracic region, (3) R1/R2 resection was performed indicating incomplete tumor removal, (4) evidence of distant tumor metastasis was observed, (5) they underwent preoperative neoadjuvant therapy, (6) pTis/T1a stage (7) Missing data.
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 |
|---|---|---|
| No interventionNo intervention | Other | high-risk |
Primary outcome
Overall Survival
Time frame: April 2022-April 2024
Overall Survival was calculated from the month and year of surgery to the time of death or last follow-up in April 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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.
Xuefeng Leng contact
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 Outcomes of Smoker and Drinker After Esophagectomy, 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.
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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. 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?
Contact Lin Peng (8618908178797, doclinpeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: April 2022-April 2024). 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 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.