Obesity and Liver Function in Oesophageal Cancer

November 2, 2019 updated by: Noel Edward Donlon, St. James's Hospital, Ireland

Elucidating the Role of Obesity, Liver Function and Pathology With Overall Outcomes in Oesophageal Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

658

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • IE
      • Dublin, IE, Ireland, D8
        • Recruiting
        • St. James's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

oesophageal cancer patients

Description

Inclusion Criteria:

  • Those undergoing oesophagectomy

Exclusion Criteria:

  • patients who only had chemotherapy/chemoradiotherapy without surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Patinets undergoing surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 1 year
1 year
Disease free survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. James's Hospital, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

November 2, 2019

First Submitted That Met QC Criteria

November 2, 2019

First Posted (ACTUAL)

November 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 2, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJH00003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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