ObesityNCT04152044
Obesity and Liver Function in Oesophageal Cancer
An observational study of Obesity and Liver Function, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity, Liver Function
- What is being tested?
- Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy
- How many people
- 658 participants
- Where
- 1 siteIreland
- Study dates
- 1 Nov 2019to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: oesophageal cancer patients
Who may be able to join
- Those undergoing oesophagectomy
Who cannot join
- patients who only had chemotherapy/chemoradiotherapy without surgery
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
St. James's Hospital
Dublin, IE, D8
Noel E Donlon, 00353863557726 ext. 00353863557726, donlonn@tcd.ie
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Liver Function
- Being tested
- Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomyOther
Patinets undergoing surgery
| Study group | Role | What they receive |
|---|---|---|
| Liver biopsy, Visceral and subcutaneous obesity | Those with histology and LFT's and quantificaiton of obesity Receives: Other: Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 1 year
Disease free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 658 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Edward Donlon, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152044
- Sponsor's protocol ID
- SJH00003
- Status last verified
- Nov 2019
- First submitted
- 2 Nov 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Role of Obesity, Liver Function and Pathology With Overall Outcomes in Oesophageal Cancer
- ClinicalTrials.gov ID
- NCT04152044
- Acronym / sponsor ID
- SJH00003
- Conditions
- Obesity, Liver Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 658 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver biopsy, Visceral and subcutaneous obesity | – | Other: Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomyThose with histology and LFT's and quantificaiton of obesity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- oesophageal cancer patients
Key inclusion criteria (1 listed)
- Those undergoing oesophagectomy
Key exclusion criteria (1 listed)
- patients who only had chemotherapy/chemoradiotherapy without surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomyPatinets undergoing surgery | Other | Liver biopsy, Visceral and subcutaneous obesity |
Primary outcome
Overall Survival
Time frame: 1 year
Disease free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Liver Function, run by St. James's Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noel E Donlon (00353863557726 ext. 00353863557726, donlonn@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.