NCT02482259

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2016

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

2.6 years

First QC Date

June 12, 2015

Last Update Submit

September 14, 2017

Conditions

Hepatocellular Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Frailty as a predictor of grade 3/4 toxicity

    Baseline, week 9 and week 18

  • Muscle mass and timed get up and go as predictors of outcome

    Baseline, week 9 and week 18

Other Outcomes (2)

  • 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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Hepatocellular cancer

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Elizabeth R Plummer, MD, MRCP, BA, DPhil

    Newcastle Unversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 26, 2015

Study Start

December 1, 2013

Primary Completion

July 19, 2016

Study Completion

July 19, 2016

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

GB(1)