Terahertz Metamaterials for Tumour Marker Concentration Identification

October 30, 2023 updated by: Durham University
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

The research the investigators plan to undertake involves the use of a paper substrate with a gold metamaterial on top or a plastic substrate with gold metamaterial on top in physical contact with paper. The metamaterial has an absorption peak within the terahertz frequency range to be investigated (0.75 - 1.1THz). The serum samples will be soaked into the paper fibres which will shift the absorption peak within the terahertz frequency range dependent on the concentration of tumour markers present in the sample. The serum samples will be surplus from samples tested for CEA, LDH, CA-125, CA 19-9, CA 15-3, total-hCG and AFP at the Durham and Darlington NHS Fondation Trust. The samples will be anonymised with the exception of which tumour marker they were tested for and the level measured.

There will be two stages to this research project the initial stage requires 15 samples per proposed marker including 15 samples (across all markers) for negative results. This will be used to identify suitable markers to consider for the second stage. Where 50 to 90 samples of each qualifying marker will be tested dependent on the number required for statistical confidence in stage two with 10 to 18 negative samples required for each qualifying marker, again dependent on the statistical requirements for each marker.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Durham, United Kingdom, DH1 3LE
        • Department of Engineering Durham University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

County Durham and Darlington NHS Foundation Trust

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with known bloodborne pathogens.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of detection for any marker
Time Frame: 18 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantifying the quality of detection per marker
Time Frame: 18 months
Percentage of detectable samples for each specific marker which showed any evidence of detection in outcome 1.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Durham University

Collaborators

County Durham and Darlington NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Actual)

October 1, 2022

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 265479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Outcomes will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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