NCT06269341

Brief 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, and those who only smoked or drank

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,957

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
14 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

14.5 years

First QC Date

February 12, 2024

Last Update Submit

February 12, 2024

Conditions

Outcomes of Smoker and Drinker After Esophagectomy

Keywords

survivalesophgeal cancersmokerdrinker

Outcome Measures

Primary Outcomes (1)

  • 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

    April 2022-April 2024

Study Arms (2)

high-risk

Smoker and Drinker with Esophageal Squamous Cell Carcinoma after Esophagectomy

Other: No intervention

low-risk

Non-Smoker and Non-Drinker with Esophageal Squamous Cell Carcinoma after Esophagectomy

Interventions

No interventionOTHER

No intervention

high-risk

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with esophageal cancer

You may qualify if:

  • patients with esophageal cancer

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

RECRUITING

Central Study Contacts

Lin Peng

CONTACT

8618908178797doclinpeng@163.com

Xuefeng Leng

CONTACT

doc.leng@uestc.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 21, 2024

Study Start

February 1, 2010

Primary Completion

July 30, 2024

Study Completion

August 30, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)