Assessment of Frailty in Patients With Advanced Hepatocel... | NCT02482259

Studies
Assessment of Frailty in Patients With Advanced Hepatocellular Cancers

NCT02482259

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Status

Completed

Last Update Posted

Sep 15, 2017Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Hepatocellular Cancer

Interventions

Not provided

Countries

United Kingdom

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2013Actual

Primary Completion Date

Jul 19, 2016Actual

Completion Date

Jul 19, 2016Actual

First Submitted Date

Jun 12, 2015

First Submission Date that Met QC Criteria

Jun 23, 2015

First Posted Date

Jun 26, 2015Estimated

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

Sep 14, 2017

Last Update Posted Date

Sep 15, 2017Actual

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

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

Detailed Description

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.

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

Retention

Enrollment

28Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage patients consenting for assessment out of number of patients approached	Number of patients consenting for the study as a percentage of the number of patients approached about the study	baseline
Time taken to complete assessments	Time taken to completed assessments recorded by clinical trials officer	Baseline, week 9 and week 18

Secondary Outcomes

Measure	Description	Time Frame
Frailty as a predictor of grade 3/4 toxicity	Frailty score at baseline and during study time predict for outcome	Baseline, week 9 and week 18
Muscle mass and timed get up and go as predictors of outcome

Other Outcomes

Measure	Description	Time Frame
Quality of Life - EORTC QCQ 30 and HCC18		Baseline, week 9 and week 18
Biomarker assessment of frailty and associated factors		Baseline, week 9 and week 18

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Hepatocellular cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth R Plummer, MD, MRCP, BA, DPhil	Newcastle Unversity	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Newcastle upon Tyne Hospitals NHS Foundation Trust		Newcastle upon Tyne		NE7 7DN	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided