CancerLEV93ANCT05295017
LEVANTIS-0093A: GAGomes for Multi-Cancer Early Detection in High-Risk Adults (LEV93A)
An observational study of Cancer, run by Elypta at 1 site in United Kingdom.
Trial summary
LEVANTIS-0093A (LEV93A) is a prospective cohort observational clinical study to validate the plasma free GAGome MCED test in adults at high risk of developing cancer ("high-risk adults"), specifically in 55-80-year-old adults with significant smoking history. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 1,235 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2022to Mar 2026
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults between 55 and 80 years old with significant smoking history ("high-risk adults").
Who may be able to join
- Adults aged 55-80 years old
- Significant smoking history, defined as current or ex-smokers and any of the following criteria:
- 30 pack year history of smoking and current smoker or quit within the last 15 years (USPSTF criteria).
- Lung cancer risk of ≥1.51% over 6 years as calculated by the PLCOM2012 score
- Lung cancer risk of ≥5% over 5 years as calculated by the LLPv2. Score
- Consenting to participate to both YLST and YLST Biomarker trials
- Able to donate a blood sample
Who cannot join
- Deemed medically unfit for sample collection
- Contraindication for study procedures or sampling
- Not consenting to participate to YKST trial
Trial locations and contacts
1 site in 1 country.
About this study
LEVANTIS-0093A (LEV93A) is a prospective cohort observational clinical study to validate the plasma free GAGome MCED test in adults at high risk of developing cancer ("high-risk adults"), specifically in 55-80-year-old adults with significant smoking history.
LEV93A will use plasma biospecimens collected within the Yorkshire Lung Screening Trial Biomarker sub-study and corresponding participant data prospectively collected within the Yorkshire Lung Screening Trial (YLST) and the Yorkshire Kidney Screening Trial (YKST) all of which are sponsored by the University of Leeds and funded by Yorkshire Cancer Research (Award references: L403, L403B L403C), in collaboration with the University of Leeds, with the University of Manchester and with the Leeds Teaching Hospitals.
- Conditions
- Cancer
- Keywords
- liquid biopsy, multi-cancer early detection, glycosaminoglycans
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the plasma free GAGome MCED test
Indicative of any-type cancer vs. no cancer diagnosis
Measured: Within 365 days after the biosampling visit
Secondary outcomes (3)
Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis)
Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis)
Measured: Within 365 days after the biosampling visit
Sensitivity and specificity of the plasma free GAGome MCED test followed by low-dose computed tomography (LDCT)
Indicative of any-type cancer vs. no cancer diagnosis in combination with LDCT
Measured: Within 365 days after the biosampling visit
Sensitivity and specificity of LDCT followed by plasma free GAGome MCED test
Indicative of any-type cancer vs. no cancer diagnosis in combination with LDCT
Measured: Within 365 days after the biosampling visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start14 Mar 2022
- Primary completionOct 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elypta
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesco Gatto, PhD, Principal investigator, Elypta AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295017
- Sponsor's protocol ID
- GR 22-016
- Acronym
- LEV93A
- Status last verified
- Sep 2024
- First submitted
- 14 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEVANTIS-0093A: GAGomes for Multi-Cancer Early Detection in High-Risk Adults (LEV93A)
- ClinicalTrials.gov ID
- NCT05295017
- Acronym / sponsor ID
- LEV93A / GR 22-016
- Conditions
- Cancer
- Keywords
- liquid biopsy, multi-cancer early detection, glycosaminoglycans
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,235 participants (actual)
- Lead sponsor
- ElyptaIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 Mar 2022 (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.
LEVANTIS-0093A (LEV93A) is a prospective cohort observational clinical study to validate the plasma free GAGome MCED test in adults at high risk of developing cancer ("high-risk adults"), specifically in 55-80-year-old adults with significant smoking history.
LEV93A will use plasma biospecimens collected within the Yorkshire Lung Screening Trial Biomarker sub-study and corresponding participant data prospectively collected within the Yorkshire Lung Screening Trial (YLST) and the Yorkshire Kidney Screening Trial (YKST) all of which are sponsored by the University of Leeds and funded by Yorkshire Cancer Research (Award references: L403, L403B L403C), in collaboration with the University of Leeds, with the University of Manchester and with the Leeds Teaching Hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults between 55 and 80 years old with significant smoking history ("high-risk adults").
Key inclusion criteria (7 listed)
- Adults aged 55-80 years old
- Significant smoking history, defined as current or ex-smokers and any of the following criteria:
- Consenting to participate to both YLST and YLST Biomarker trials
- Able to donate a blood sample
Key exclusion criteria (3 listed)
- Deemed medically unfit for sample collection
- Contraindication for study procedures or sampling
- Not consenting to participate to YKST trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of the plasma free GAGome MCED test
Time frame: Within 365 days after the biosampling visit
Indicative of any-type cancer vs. no cancer diagnosis
3 secondary outcomes
Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis)
Time frame: Within 365 days after the biosampling visit
Sensitivity and specificity of the plasma free GAGome MCED test followed by low-dose computed tomography (LDCT)
Time frame: Within 365 days after the biosampling visit
Sensitivity and specificity of LDCT followed by plasma free GAGome MCED test
Time frame: Within 365 days after the biosampling visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Francesco Gatto, PhD principal investigator
Elypta AB
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 Cancer, run by Elypta 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Sensitivity and specificity of the plasma free GAGome MCED test (time frame: Within 365 days after the biosampling visit). 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 19 Sep 2024.