Obesity and Liver Function in Oesophageal Cancer | NCT04152044

Studies
Obesity and Liver Function in Oesophageal Cancer

NCT04152044

Sponsor

St. James's Hospital, Ireland

Status

Unknown status

Last Update Posted

Nov 5, 2019Actual

Enrollment

658Estimated

Phase

Not provided

Conditions

Obesity
Liver Function

Interventions

Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy

Countries

Ireland

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 2019

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

Nov 1, 2019Actual

Primary Completion Date

Jul 1, 2020Estimated

Completion Date

Nov 1, 2020Estimated

First Submitted Date

Nov 2, 2019

First Submission Date that Met QC Criteria

Nov 2, 2019

First Posted Date

Nov 5, 2019Actual

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

Nov 2, 2019

Last Update Posted Date

Nov 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Noel Edward Donlon, Principal Investigator, St. James's Hospital, IrelandPrincipal Investigator

Lead Sponsor

St. James's Hospital, IrelandOTHER

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

There is an established link between sarcopenia and outcomes in oesophageal cancer. There is scant reports in the literature regarding the influences of different obesity in different compartments.

Detailed Description

Oesophageal cancer rates are increasing as a result of obesity in Western society. Thr investigators are evaluating the influence of viscerala dn subcutaneous obesity on overall outcomes of the participants. In addition the investigators are evaluating if there is a correlation with Liver Function Tests and liver histopathology such as steatosis on survival in participants and post operative sequele.

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

658Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver biopsy, Visceral and subcutaneous obesity		Those with histology and LFT's and quantificaiton of obesity	Other: Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy	Other	Patinets undergoing surgery	Liver biopsy, Visceral and subcutaneous obesity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival		1 year
Disease free survival		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those undergoing oesophagectomy

Exclusion Criteria:

patients who only had chemotherapy/chemoradiotherapy without surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

oesophageal cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Noel E Donlon	Contact	00353863557726	00353863557726	donlonn@tcd.ie

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. James's Hospital	Recruiting	Dublin	IE	D8	Ireland

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

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016629	Esophagectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided