Outcomes of Smoker and Drinker With Esophageal Squamous C... | NCT06269341

Studies
Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy

NCT06269341

Sponsor

Sichuan Cancer Hospital and Research Institute

Status

Unknown status

Last Update Posted

Feb 21, 2024Actual

Enrollment

2,957Estimated

Phase

Not provided

Conditions

Outcomes of Smoker and Drinker After Esophagectomy

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2010Actual

Primary Completion Date

Jul 30, 2024Estimated

Completion Date

Aug 30, 2024Estimated

First Submitted Date

Feb 12, 2024

First Submission Date that Met QC Criteria

Feb 12, 2024

First Posted Date

Feb 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2024

Last Update Posted Date

Feb 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yongtao Han, MD, Sichuan Cancer Hospital and Research InstitutePrincipal Investigator

Lead Sponsor

Sichuan Cancer Hospital and Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,957Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	high-risk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients with esophageal cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lin Peng	Contact	8618908178797		doclinpeng@163.com
Xuefeng Leng	Contact			doc.leng@uestc.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sichuan Cancer Hospital and Research Institute	Recruiting	Chengdu	Sichuan	610041	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided