LEVANTIS-0087A: GAGomes for Multi-Cancer Early Detection in Asymptomatic Adults (LEV87A)
Recruiting
Observational Study
Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Observational
Participants needed
9,170 (estimated)
Sponsor
Elypta · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
Sub-Study 1
Inclusion Criteria
* 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 diagno…
Sub-Study 1
Inclusion Criteria
* 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:
* 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
Exclusion Criteria
* 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)
Sub-Study 2
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
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