Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT05235009

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

Led by Elypta · Updated on 2024-09-19

9170

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 35 to 80 years at the baseline visit
  • Any gender
  • Not receiving treatment for or under surveillance for cancer at the baseline visit
  • No signs of being monitored for or suspected of having cancer at the baseline visit
  • No cancer diagnosis before or on the baseline visit, or any previous cancer was curatively treated at least 5 years before baseline
  • Available biospecimens for both EDTA-plasma and urine at the baseline visit
Not Eligible

You will not qualify if you...

  • No available data for cancer diagnosis up to 365 days after the baseline visit
  • Only a self-reported cancer diagnosis within 365 days after baseline without histopathological or clinical confirmation
  • Subjects not matching the pre-specified target population criteria defined in the study analysis plan

AI-Screening

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Trial Site Locations

Total: 1 location

1

Elypta AB

Stockholm, Sweden

Actively Recruiting

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Research Team

F

Francesco Gatto, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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