Hepatocellular CancerFAC-LNCT02482259
Assessment of Frailty in Patients With Advanced Hepatocellular Cancers
An observational study of Hepatocellular Cancer, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study is looking at the feasibility of performing frailty assessments on patients with advanced hepatocellular cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Cancer
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2013to 19 Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Hepatocellular cancer
Who may be able to join
- 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
Who cannot join
- N/A
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
About this study
This study is looking at the feasibility of performing frailty assessments on patients with advanced hepatocellular cancer.
Read the 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.
- Conditions
- Hepatocellular Cancer
- Medical subject headings
- Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Time taken to complete assessments
Time taken to completed assessments recorded by clinical trials officer
Measured: Baseline, week 9 and week 18
Secondary outcomes (2)
Frailty as a predictor of grade 3/4 toxicity
Frailty score at baseline and during study time predict for outcome
Measured: Baseline, week 9 and week 18
Muscle mass and timed get up and go as predictors of outcome
muscle mass as measured on routine CT scans and get up and go as measured in frailty score
Measured: Baseline, week 9 and week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start1 Dec 2013
- Primary completion19 Jul 2016
- Study completion19 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies 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
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth R Plummer, MD, MRCP, BA, DPhil, Principal investigator, Newcastle Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482259
- Sponsor's protocol ID
- 6730
- Acronym
- FAC-L
- Status last verified
- Sep 2017
- First submitted
- 12 Jun 2015
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Frailty in Patients With Advanced Hepatocellular Cancers
- ClinicalTrials.gov ID
- NCT02482259
- Acronym / sponsor ID
- FAC-L / 6730
- Conditions
- Hepatocellular Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 19 Jul 2016 (actual)
- Study completion
- 19 Jul 2016 (actual)
- First posted
- 26 Jun 2015 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Hepatocellular cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- N/A
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage patients consenting for assessment out of number of patients approached
Time frame: baseline
Number of patients consenting for the study as a percentage of the number of patients approached about the study
Time taken to complete assessments
Time frame: Baseline, week 9 and week 18
Time taken to completed assessments recorded by clinical trials officer
2 secondary outcomes
Frailty as a predictor of grade 3/4 toxicity
Time frame: Baseline, week 9 and week 18
Muscle mass and timed get up and go as predictors of outcome
Time frame: Baseline, week 9 and week 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
Related trials for Hepatocellular Cancer
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
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.
Elizabeth R Plummer, MD, MRCP, BA, DPhil principal investigator
Newcastle Unversity
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 Hepatocellular Cancer, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 15 Sep 2017. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage patients consenting for assessment out of number of patients approached (time frame: baseline). 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 15 Sep 2017.