LEVANTIS-0087A: GAGomes for Multi-Cancer Early Detection in Asymptomatic Adults (LEV87A)

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.

Eligibility

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.

Conditions1

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