Status:
RECRUITING
LEVANTIS-0087A: GAGomes for Multi-Cancer Early Detection in Asymptomatic Adults (LEV87A)
Lead Sponsor:
Elypta
Conditions:
Cancer
Eligibility:
All Genders
18-80 years
Brief 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 mul...
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 r...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
9170 Patients enrolled
Trial Details
Trial ID
NCT05235009
Start Date
February 1 2022
End Date
December 1 2026
Last Update
September 19 2024
Active Locations (1)
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1
Elypta AB
Stockholm, Sweden