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

NCT05235009 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 9170

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Combined free GAGome MCED 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)

Sponsors & Collaborators

  • Elypta

    lead INDUSTRY

Principal Investigators

  • Francesco Gatto, PhD · Elypta AB

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05235009 on ClinicalTrials.gov