Terahertz Metamaterials for Tumour Marker Concentration Identification

Malignant Tumour Clinical Trial

Official title:

Terahertz Metamaterials for Tumour Marker Concentration Identification

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04125524
• Other study ID #: 265479
• Status: Suspended
• Start date: May 17, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: October 2023
• Source: Durham University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 90
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Tumour
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Department of Engineering Durham University	Durham

Sponsors (2)

Lead Sponsor	Collaborator
Durham University	County Durham and Darlington NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantifying the quality of detection per marker	Percentage of detectable samples for each specific marker which showed any evidence of detection in outcome 1.	18 months