NCT06134245

Brief Summary

To validate the usability and safety of the Liberty Analyser.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

November 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 8, 2023

Last Update Submit

November 10, 2023

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • The Entia Liberty Analyser is easy to use

    Users can easily carry out a test using the Entia Liberty Analyser

    Through study completion, 1 day

  • The Entia Liberty Analyser is safe to use

    Results obtained using the Entia Liberty Analyser are valid and reliable

    Through study completion, 1 day

Interventions

Entia LibertyDEVICE

Home monitoring

Eligibility Criteria

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

Adults with a diagnosis of solid tumour cancer, who are currently undergoing systemic anti-cancer therapy

You may qualify if:

  • Undergoing systemic anti-cancer therapy (SACT)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 at enrolment
  • Adequate English language skills (not requiring a translator) to participate in participant training and use the Entia Liberty analyser
  • Patients capable of providing written informed consent

You may not qualify if:

  • History or current diagnosis of haematological malignancy
  • Patients with eyesight or hearing limitations or other disabilities that preclude the use of the Entia Liberty analyser or participation in training
  • Inadequate use and understanding of the English language, requiring a translator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Hannah Rawlinson-Smith

CONTACT

020 3020 0030hannah.rawlinson-smith@entia.co

Madeline Lok

CONTACT

020 3020 0030madeline.lok@entia.co

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 18, 2023

Study Start

March 1, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11