Clinical trial · Observational
LEVANTIS-0087A: GAGomes for Multi-Cancer Early Detection in Asymptomatic Adults (LEV87A)
NCT05235009CI-TRIAL-00080783LEV87ArecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined free GAGome MCED test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Sub-Study 1
- description
- 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.
- interventionNames
- Diagnostic Test: Combined free GAGome MCED test
- label
- Sub-Study 2
- description
- 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).
- interventionNames
- Diagnostic Test: Combined free GAGome MCED test
Primary outcomes (1)
- measure
- Sensitivity and specificity of the combined free GAGome MCED test
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.