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Assessment of Frailty in Elderly Patients With Advanced Cancers (FAC-C)

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ClinicalTrials.gov Identifier: NCT02482285
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary:
This study is looking at the feasibility of performing frailty assessments on elderly patients with advanced cancers

Condition or disease
Cancer

Detailed Description:

This study is primarily looking to see if it is feasible to assess frailty in patients age 70 years and above with advanced cancers. it is also evaluating whether there may be any correlation between these assessments and toxicity and treatment and outcome.

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

The assessments will be performed at baseline, week 12 and week 24.

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


Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Frailty in Elderly Patients With Advanced Cancers
Study Start Date : December 1, 2013
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup




Primary Outcome Measures :
  1. Percentage patients consenting for assessments out of number approached [ Time Frame: Baseline ]
    Number of patients consenting for the study as a percentage of number of patients approached about the study.

  2. Time taken to complete assessments [ Time Frame: Baseline, week 12 and week 24 ]

Secondary Outcome Measures :
  1. Frailty as a predictor of grade 3/4 toxicity [ Time Frame: baseline ]
    Evaluate whether there is a possible correlation between frailty score at baseline and development of grade 3/4 toxicity during anticancer treatment

  2. Sarcopenia as a predictor of outcome [ Time Frame: baseline, week 12 and week 24 ]
    sarcopenia at baseline and over time as a predictor of outcome

  3. Quality of life EORTC QCQ 30 [ Time Frame: baseline, week 12 and week 24 ]
  4. Biomarker assessment of frailty and associated factors which may include genetic analysis [ Time Frame: baseline, week 12 and week 24 ]

Biospecimen Retention:   Samples With DNA
Blood samples and baseline, week 12 and weeks 24


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced cancers
Criteria

Inclusion Criteria:

  • Histological diagnosis of advanced carcinoma - not suitable for curative treatment
  • Age 70 years or over
  • seen by an oncologist for consideration of palliative systemic medical therapy and decision regarding management already made
  • WHO Performance Status 0-2
  • Written informed consent

Exclusion Criteria:

  • Hepatocellular cancer
  • Prostate cancer
  • Breast cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482285


Contacts
Contact: Linda Hogarth 00 44 1912138454 linda.hogarth@nuth.nhs.uk

Locations
United Kingdom
Newcastle upon Tyne NHS Trust Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
Principal Investigator: Alastair Greystoke, MRCP, PhD, MBChB, MSc Newcastle University

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02482285     History of Changes
Other Study ID Numbers: 6731
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017