Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04125524
Status:
SUSPENDED
Last Update Posted:
2023-11-01
First Post:
2019-10-08
Brief Title:
Terahertz Metamaterials for Tumour Marker Concentration Identification
Sponsor:
Durham University
Organization:
Durham University
Study Overview
Official Title:
Terahertz Metamaterials for Tumour Marker Concentration Identification
Status:
SUSPENDED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PhD Student completed primary study Awaiting a new student to take over the project for the secondary objective
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 075 - 11THz 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None