Predictive Factors of Survival With and Without Repetitio... | NCT03410758

Studies
Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus

NCT03410758

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Feb 7, 2018Actual

Enrollment

245Actual

Phase

Not provided

Conditions

Esophageal Cancer
Esophageal Surgery Cancer
Overall Survival

Interventions

Not provided

Countries

France

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2016Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jan 19, 2018

First Submission Date that Met QC Criteria

Jan 24, 2018

First Posted Date

Jan 25, 2018Actual

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 6, 2018

Last Update Posted Date

Feb 7, 2018Actual

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

Prospective study of Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus

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

245Actual

Measure	Description	Time Frame
Overall survival		10 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing during inclusion time carcinologic esophagectomy for esophageal cancer (Adenocarcinoma or epidermoid carcinoma)

Exclusion Criteria: Mortality within 90 postoperative days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing esophagectomy for esophageal cancer

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided