Assessment of Frailty in Patients With Advanced Hepatocellular Cancers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-01

Study Completion Date

2016-07-19

Brief Summary

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This study is looking at the feasibility of performing frailty assessments on patients with advanced hepatocellular cancer.

Detailed Description

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This study is primarily looking to see if it is feasible to assess frailty in patients with advanced hepatocellular cancer. It is also evaluating whether there may be any correlation between these assessments and toxicity of treatment and outcome.

The assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed measuring muscle mass from imaging performed as part of routine clinical care.

The assessments will be performed at baseline on entry into the study, at week 9 and week 18.

There is the option for patients to also donate a blood samples for research purposes.

Conditions

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Hepatocellular Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of hepatocellular cancer not suitable for curative treatment
* Seen by an oncologist or hepatologist for consideration of palliative treatment and a decision regarding management already made
* WHO Performance status 0-2
* Childs Pugh Score A or B
* Written informed consent

Exclusion Criteria

N/A

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth R Plummer, MD, MRCP, BA, DPhil

Role: PRINCIPAL_INVESTIGATOR

Newcastle Unversity

Locations

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Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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6730

Identifier Type: -

Identifier Source: org_study_id