NCT02482285

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

June 4, 2014

Completed
1 year 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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2016

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

June 12, 2015

Last Update Submit

October 17, 2022

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • Percentage patients consenting for assessments out of number approached

    Number of patients consenting for the study as a percentage of number of patients approached about the study.

    Baseline

  • Time taken to complete assessments

    Length of time participants take to complete study assessments

    Baseline, week 12 and week 24

Secondary Outcomes (4)

  • Frailty as a predictor of grade 3/4 toxicity

    baseline

  • Sarcopenia as a predictor of outcome

    baseline, week 12 and week 24

  • Quality of life EORTC QCQ 30

    baseline, week 12 and week 24

  • Biomarker assessment of frailty and associated factors which may include genetic analysis

    baseline, week 12 and week 24

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced cancers

You may qualify if:

  • 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

You may not qualify if:

  • Hepatocellular cancer
  • Prostate cancer
  • Breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newcastle upon Tyne NHS Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and baseline, week 12 and weeks 24

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Alastair Greystoke, MRCP, PhD, MBChB, MSc

    Newcastle University

    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

June 4, 2014

Primary Completion

January 25, 2016

Study Completion

January 25, 2016

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations

GB(1)