Assessment of Frailty in Elderly Patients With Advanced Cancers (FAC-C)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02482285|
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : September 15, 2017
|Condition or disease|
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|
|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|
- 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.
- Time taken to complete assessments [ Time Frame: Baseline, week 12 and week 24 ]
- 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
- 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
- Quality of life EORTC QCQ 30 [ Time Frame: baseline, week 12 and week 24 ]
- 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
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
|Contact: Linda Hogarth||00 44 email@example.com|
|Newcastle upon Tyne NHS Trust||Recruiting|
|Newcastle upon Tyne, United Kingdom, NE7 7DN|
|Principal Investigator:||Alastair Greystoke, MRCP, PhD, MBChB, MSc||Newcastle University|