Malignant TumourNCT04125524
Terahertz Metamaterials for Tumour Marker Concentration Identification
An observational study of Malignant Tumour, run by Durham University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Malignant Tumour
- What is being tested?
- Terahertz metamaterials
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2021to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: County Durham and Darlington NHS Foundation Trust
Who may be able to join
- 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.
Who cannot join
- Patients with known bloodborne pathogens.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Engineering Durham University
Durham, DH1 3LE
About this study
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.
Read the 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.
- Conditions
- Malignant Tumour
- Being tested
- Terahertz metamaterials
- Keywords
- Tumour markers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terahertz metamaterialsDiagnostic test
A diagnostic test used to identify specific tumour markers will be carried out on serum samples using terahertz metamaterials.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
Quantifying the quality of detection per marker
Percentage of detectable samples for each specific marker which showed any evidence of detection in outcome 1.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start17 May 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2025 (estimated)
Why it stopped: PhD Student completed primary study. Awaiting a new student to take over the project for the secondary objective.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durham University
- Sponsor type
- University, hospital or other
- Collaborators
- County Durham and Darlington NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125524
- Sponsor's protocol ID
- 265479
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2019
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Outcomes will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terahertz Metamaterials for Tumour Marker Concentration Identification
- ClinicalTrials.gov ID
- NCT04125524
- Acronym / sponsor ID
- 265479
- Conditions
- Malignant Tumour
- Keywords
- Tumour markers
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: PhD Student completed primary study. Awaiting a new student to take over the project for the secondary objective.
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Durham UniversityUniversity, hospital or other
- Collaborators
- County Durham and Darlington NHS Foundation Trust
- Study start
- 17 May 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- County Durham and Darlington NHS Foundation Trust
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with known bloodborne pathogens.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terahertz metamaterialsA diagnostic test used to identify specific tumour markers will be carried out on serum samples using terahertz metamaterials. | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Quantifying the quality of detection per marker
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No. Outcomes will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumour, run by Durham University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of detection for any marker (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.