CancerLEV87ANCT05235009
LEVANTIS-0087A: GAGomes for Multi-Cancer Early Detection in Asymptomatic Adults (LEV87A)
An observational study of Cancer, run by Elypta at 1 site in Sweden.
Trial summary
LEVANTIS-0087A (LEV87A) is a retrospective in vitro diagnostics clinical validation population cohort-based case-control study to validate the diagnostic performance of free GAGome-based tests for multi-cancer early detection (MCED) in adults asymptomatic for cancer and with no recent history of cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Combined free GAGome MCED test
- How many people
- 9,170 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults between 35 to 80 years old asymptomatic for cancer and with no recent history of cancer.
Who may be able to join
- Case Arm:
- At the baseline visit, >18 years old, any gender
- At the baseline visit, available biospecimens for both EDTA-plasma and urine
- Diagnosis of cancer before or at the baseline visit or diagnosis of cancer after the baseline visit
- If a diagnosis of cancer before or at the baseline visit, then no antineoplastic treatment between the date of diagnosis and the baseline visit
- Control Arm:
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- At the baseline visit, >18 years old, any gender
- Not receiving treatment for or under surveillance for cancer at the baseline visit
- No indications of being monitored for or under consideration for suspected cancer at the baseline visit
- No diagnosis of cancer before or on the baseline visit or if any previous diagnosis of cancer, then cancer must have been curatively treated ≥ 5 years before the baseline visit
- No diagnosis of cancer within at least 365 days after the baseline visit
- At the baseline visit, available biospecimens for both EDTA-plasma and urine
- Exploratory Arm:
- Same as Control Arm and type 2 diabetes or hypertension or BMI > 30 at the baseline visit
- At the baseline visit, 35 - 80 years old, any gender
- Not receiving treatment for or under surveillance for cancer at the baseline visit
- No indications of being monitored for or under consideration for suspected cancer at the baseline visit
- No diagnosis of cancer before or on the baseline visit or if any previous diagnosis of cancer, then cancer must have been curatively treated ≥ 5 years before the baseline visit
- At the baseline visit, available biospecimens for both EDTA-plasma and urine
Who cannot join
- Case Arm:
- No available data for diagnosis of cancer starting 90 days before the baseline visit and up to 365 days after the baseline visit
- A subject with only a self-reported diagnosis of cancer (either in the 90 days before or in the 365 days after the baseline visit), and absence of a histopathological or clinically indicated diagnosis of cancer, according to biobank database(s), or through linkage with cancer registry(ies)
- Control Arm and Exploratory Arm:
- No available data for diagnosis of cancer up to 365 days after or on the baseline visit
- A histopathological or clinically indicated diagnosis of cancer within 365 days from the baseline visit, according to biobank database(s), or through linkage with cancer registry(ies)
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- Sub-Study 2
- No available data for diagnosis of cancer up to 365 days after the baseline visit
- A subject with only a self-reported diagnosis of cancer in the 365 days after the baseline visit and absence of a histopathological or clinically indicated diagnosis of cancer, according to biobank database(s), or through linkage with cancer registry(ies)
- Subjects not meeting the specifications for the target population eventually changed during test development in Sub-Study 1. Note that these specifications are pre-specified in the Statistical Analysis Plan and will be applied if they meet pre-specified acceptance criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
LEVANTIS-0087A (LEV87A) is a retrospective in vitro diagnostics clinical validation population cohort-based case-control study to validate the diagnostic performance of free GAGome-based tests for multi-cancer early detection (MCED) in adults asymptomatic for cancer and with no recent history of cancer.
Read the detailed description
Multi-cancer early detection (MCED) could prevent 26% of all cancer-related deaths - an effect larger than averting all deaths from breast cancer alone. However, a societal program to implement MCED requires a practical, noninvasive, and affordable diagnostic modality that is sensitive and specific to all forms of cancers. Liquid biopsies represent front-runner modalities to this end but virtually all of them rely on genomics biomarkers, typically circulating free DNA (cfDNA), which capture <20% of cancers in stage I. In addition, they miss certain cancer types that shed little cfDNA, like brain or genitourinary tumors. Pilot studies show that free glycosaminoglycan profiles in plasma and urine, or free GAGomes, were promising noninvasive biomarkers of cancer metabolism that detected over a third of stage I cancers across 14 types, including brain and genitourinary tumors.
LEVANTIS-0087A (LEV87A) is a retrospective in vitro diagnostics clinical validation population cohort-based case-control study to develop free GAGome-based tests for multi-cancer early detection in adults asymptomatic for cancer and with no recent history of cancer (Sub-Study 1) and to validate their diagnostic performance in the target population (Sub-Study 2).
LEV87A uses retrospectively collected biospecimens from one or more population-based biobanks representative of the target population.
- Conditions
- Cancer
- Being tested
- Combined free GAGome MCED test
- Keywords
- liquid biopsy, multi-cancer early detection, glycosaminoglycans
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined free GAGome MCED testDiagnostic test
The combined free GAGome MCED test aggregates measurements of plasma and urine GAGomes (the exhaustive human glycosaminoglycan profile) into a diagnostic score, the combined free GAGome MCED score. The measurements are performed using MIRAM MCED Kits (Elypta AB) and the scores are computed using Elypta SKY Software (Elypta AB)
| Study group | Role | What they receive |
|---|---|---|
| Sub-Study 1 | Adults >= 18 years old with cancer or imminent cancer diagnosis (cases) versus cancer-free and no imminent cancer diagnosis (controls).
Sub-Study 1 is intended for the development of 3 free GAGome MCED tests. Receives: Diagnostic Test: Combined free GAGome MCED test | |
| Sub-Study 2 | Adults between 35 - 80 years old asymptomatic for cancer and with no recent history of cancer (> 5 years since curative-intent treatment for cancer).
Sub-Study 2 is intended for the validation of the combined free GAGome MCED test (primary endpoint) and the plasma and urine free GAGome MCED tests (secondary endpoints). Receives: Diagnostic Test: Combined free GAGome MCED test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the combined free GAGome MCED test
Indicative of any-type cancer vs. no cancer diagnosis
Measured: Within 365 days after the baseline visit
Secondary outcomes (4)
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 baseline visit
Sensitivity and specificity of the urine free GAGome MCED test
Indicative of any-type cancer vs. no cancer diagnosis
Measured: Within 365 days after the baseline visit
Accuracy to the "putative cancer location" (PCL) model in the case (cancer) arm
Accuracy to the "putative cancer location" (PCL) model in the case (cancer) arm
Measured: Within 365 days after the baseline visit
Overall survival (OS) in the case (cancer) arm
Overall survival (OS) in the case (cancer) arm
Measured: From baseline visit until the date of death from any cause, assessed up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Feb 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 9,170 participants (estimated)
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
- NCT05235009
- Sponsor's protocol ID
- GR 21-063
- Acronym
- LEV87A
- Status last verified
- Sep 2024
- First submitted
- 7 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-0087A: GAGomes for Multi-Cancer Early Detection in Asymptomatic Adults (LEV87A)
- ClinicalTrials.gov ID
- NCT05235009
- Acronym / sponsor ID
- LEV87A / GR 21-063
- Conditions
- Cancer
- Keywords
- liquid biopsy, multi-cancer early detection, glycosaminoglycans
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,170 participants (estimated)
- Lead sponsor
- ElyptaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Feb 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-0087A (LEV87A) is a retrospective in vitro diagnostics clinical validation population cohort-based case-control study to validate the diagnostic performance of free GAGome-based tests for multi-cancer early detection (MCED) in adults asymptomatic for cancer and with no recent history of cancer.
Detailed description
Multi-cancer early detection (MCED) could prevent 26% of all cancer-related deaths - an effect larger than averting all deaths from breast cancer alone. However, a societal program to implement MCED requires a practical, noninvasive, and affordable diagnostic modality that is sensitive and specific to all forms of cancers. Liquid biopsies represent front-runner modalities to this end but virtually all of them rely on genomics biomarkers, typically circulating free DNA (cfDNA), which capture <20% of cancers in stage I. In addition, they miss certain cancer types that shed little cfDNA, like brain or genitourinary tumors. Pilot studies show that free glycosaminoglycan profiles in plasma and urine, or free GAGomes, were promising noninvasive biomarkers of cancer metabolism that detected over a third of stage I cancers across 14 types, including brain and genitourinary tumors.
LEVANTIS-0087A (LEV87A) is a retrospective in vitro diagnostics clinical validation population cohort-based case-control study to develop free GAGome-based tests for multi-cancer early detection in adults asymptomatic for cancer and with no recent history of cancer (Sub-Study 1) and to validate their diagnostic performance in the target population (Sub-Study 2).
LEV87A uses retrospectively collected biospecimens from one or more population-based biobanks representative of the target population.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub-Study 1 | – | Diagnostic Test: Combined free GAGome MCED testAdults >= 18 years old with cancer or imminent cancer diagnosis (cases) versus cancer-free and no imminent cancer diagnosis (controls). Sub-Study 1 is intended for the development of 3 free GAGome MCED tests. |
| Sub-Study 2 | – | Diagnostic Test: Combined free GAGome MCED testAdults between 35 - 80 years old asymptomatic for cancer and with no recent history of cancer (> 5 years since curative-intent treatment for cancer). Sub-Study 2 is intended for the validation of the combined free GAGome MCED test (primary endpoint) and the plasma and urine free GAGome MCED tests (secondary endpoints). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults between 35 to 80 years old asymptomatic for cancer and with no recent history of cancer.
Key inclusion criteria (19 listed)
- Case Arm:
- Control Arm:
- Exploratory Arm:
- At the baseline visit, 35 - 80 years old, any gender
- Not receiving treatment for or under surveillance for cancer at the baseline visit
Key exclusion criteria (10 listed)
- Case Arm:
- Control Arm and Exploratory Arm:
- Sub-Study 2
- No available data for diagnosis of cancer up to 365 days after the baseline visit
- A subject with only a self-reported diagnosis of cancer in the 365 days after the baseline visit and absence of a histopathological or clinically indicated diagnosis of cancer, according to biobank database(s), or through linkage with cancer registry(ies)
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 |
|---|---|---|
| Combined free GAGome MCED testThe combined free GAGome MCED test aggregates measurements of plasma and urine GAGomes (the exhaustive human glycosaminoglycan profile) into a diagnostic score, the combined free GAGome MCED score. The measurements are performed using MIRAM MCED Kits (Elypta AB) and the scores are computed using Elypta SKY Software (Elypta AB) | Diagnostic test | Sub-Study 1, Sub-Study 2 |
Primary outcome
Sensitivity and specificity of the combined free GAGome MCED test
Time frame: Within 365 days after the baseline visit
Indicative of any-type cancer vs. no cancer diagnosis
4 secondary outcomes
Sensitivity and specificity of the plasma free GAGome MCED test
Time frame: Within 365 days after the baseline visit
Sensitivity and specificity of the urine free GAGome MCED test
Time frame: Within 365 days after the baseline visit
Accuracy to the "putative cancer location" (PCL) model in the case (cancer) arm
Time frame: Within 365 days after the baseline visit
Overall survival (OS) in the case (cancer) arm
Time frame: From baseline visit until the date of death from any cause, assessed up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
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 Sweden.
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 19 inclusion and 10 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: looking for participants now, 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Gatto, PhD (+46 (0)8 520 27 885, info@elypta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the combined free GAGome MCED test (time frame: Within 365 days after the baseline 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.