- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06269341
Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy (OSinEC)
February 12, 2024 updated by: Yongtao Han, Sichuan Cancer Hospital and Research Institute
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
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
2957
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lin Peng
- Phone Number: 8618908178797
- Email: doclinpeng@163.com
Study Contact Backup
- Name: Xuefeng Leng
- Email: doc.leng@uestc.edu.cn
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- Sichuan Cancer Hospital and Research Institute
-
Contact:
- Lin Peng, M.D.
- Phone Number: +8618908190013
- Email: penglinms@126.com
-
Contact:
- Wenwu He, M.D.
- Phone Number: +8613350055340
- Email: wenwu_he@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients with esophageal cancer
Description
Inclusion Criteria:
patients with esophageal cancer
Exclusion Criteria:
(1) 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
high-risk
Smoker and Drinker with Esophageal Squamous Cell Carcinoma after Esophagectomy
|
No intervention
|
|
low-risk
Non-Smoker and Non-Drinker with Esophageal Squamous Cell Carcinoma after Esophagectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
April 2022-April 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2010
Primary Completion (Estimated)
July 30, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
February 12, 2024
First Submitted That Met QC Criteria
February 12, 2024
First Posted (Estimated)
February 21, 2024
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
- SCCH-TS2208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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