NCT04125524

Brief Summary

The research the investigators plan to undertake involves the use of a metamaterial at terahertz frequencies. Serum samples will be tested using the metamaterial to determine if this method can be used to measure the concentration of tumour markers present in the sample. Patients who have been tested for CEA, LDH, CA-125, CA 19-9, CA 15-3, total-hCG and AFP will be used for both the positive and negative samples.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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

October 8, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

October 8, 2019

Last Update Submit

October 30, 2023

Conditions

Keywords

Tumour markers

Outcome Measures

Primary Outcomes (1)

  • Evidence of detection for any marker

    Any correlation showing a difference between samples with marker concentrations above and below the standard threshold values used for tests within the NHS.

    18 months

Secondary Outcomes (1)

  • Quantifying the quality of detection per marker

    18 months

Interventions

A diagnostic test used to identify specific tumour markers will be carried out on serum samples using terahertz metamaterials.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

County Durham and Darlington NHS Foundation Trust

You may qualify if:

  • Any patient recommended by their health professional to be tested for any of the tumour markers being studied at County Durham and Darlington NHS Foundation Trust for any reason.

You may not qualify if:

  • Patients with known bloodborne pathogens.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Engineering Durham University

Durham, DH1 3LE, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surplus serum samples remaining after hospital tests.

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 14, 2019

Study Start

May 17, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2025

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Outcomes will be shared.

Locations