NCT04152044

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
658

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

November 2, 2019

Last Update Submit

November 2, 2019

Conditions

ObesityLiver Function

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    1 year

  • Disease free survival

    1 year

Study Arms (1)

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

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

Patinets undergoing surgery

Liver biopsy, Visceral and subcutaneous obesity

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

oesophageal cancer patients

You may qualify if:

  • Those undergoing oesophagectomy

You may not qualify if:

  • patients who only had chemotherapy/chemoradiotherapy without surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. James's Hospital

Dublin, IE, D8, Ireland

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Noel E Donlon

CONTACT

00353863557726donlonn@tcd.ie

Study Design

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

Study Record Dates

First Submitted

November 2, 2019

First Posted

November 5, 2019

Study Start

November 1, 2019

Primary Completion

July 1, 2020

Study Completion

November 1, 2020

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)