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LEVANTIS-0093A: GAGomes for Multi-Cancer Early Detection in High-Risk Adults (LEV93A) (LEV93A)

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ClinicalTrials.gov Identifier: NCT05295017
Recruitment Status : Recruiting
First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Elypta

Brief Summary:

LEVANTIS-0093A (LEV93A) is a prospective cohort observational clinical study to validate the plasma free GAGome MCED test in adults at high risk of developing cancer ("high-risk adults"), specifically in 55-80-year-old adults with significant smoking history.

LEV93A will use plasma biospecimens collected within the Yorkshire Lung Screening Trial Biomarker sub-study and corresponding participant data prospectively collected within the Yorkshire Lung Screening Trial (YLST) and the Yorkshire Kidney Screening Trial (YKST) all of which are sponsored by the University of Leeds and funded by Yorkshire Cancer Research (Award references: L403, L403B L403C), in collaboration with the University of Leeds, with the University of Manchester and with the Leeds Teaching Hospitals.


Condition or disease
Cancer

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Study Type : Observational
Estimated Enrollment : 1256 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LEVANTIS-0093A: GAGomes for Multi-Cancer Early Detection in High-Risk Adults (LEV93A)
Actual Study Start Date : March 14, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2025



Primary Outcome Measures :
  1. Sensitivity and specificity of the plasma free GAGome MCED test [ Time Frame: Within 365 days after the biosampling visit ]
    Indicative of any-type cancer vs. no cancer diagnosis


Secondary Outcome Measures :
  1. Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis) [ Time Frame: Within 365 days after the biosampling visit ]
    Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis)

  2. Sensitivity and specificity of the plasma free GAGome MCED test followed by low-dose computed tomography (LDCT) [ Time Frame: Within 365 days after the biosampling visit ]
    Indicative of any-type cancer vs. no cancer diagnosis in combination with LDCT

  3. Sensitivity and specificity of LDCT followed by plasma free GAGome MCED test [ Time Frame: Within 365 days after the biosampling visit ]
    Indicative of any-type cancer vs. no cancer diagnosis in combination with LDCT


Biospecimen Retention:   Samples Without DNA
Prospectively collected blood samples sourced from patients enrolled in study


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults between 55 and 80 years old with significant smoking history ("high-risk adults").
Criteria

Inclusion Criteria

  • Adults aged 55-80 years old
  • Significant smoking history, defined as current or ex-smokers and any of the following criteria:

    • 30 pack year history of smoking and current smoker or quit within the last 15 years (USPSTF criteria).
    • Lung cancer risk of ≥1.51% over 6 years as calculated by the PLCOM2012 score
    • Lung cancer risk of ≥5% over 5 years as calculated by the LLPv2. Score
  • Consenting to participate to both YLST and YLST Biomarker trials
  • Able to donate a blood sample

Exclusion Criteria

  • Deemed medically unfit for sample collection
  • Contraindication for study procedures or sampling
  • Not consenting to participate to YKST trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05295017


Contacts
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Contact: Francesco Gatto, PhD +46 (0)8 520 27 885 info@elypta.com

Locations
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United Kingdom
Leads Teaching Hospitals Trust Recruiting
Leeds, United Kingdom
Contact: Francesco Gatto         
Sponsors and Collaborators
Elypta
Investigators
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Principal Investigator: Francesco Gatto, PhD Elypta AB
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Responsible Party: Elypta
ClinicalTrials.gov Identifier: NCT05295017    
Other Study ID Numbers: GR 22-016
First Posted: March 24, 2022    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elypta:
liquid biopsy
multi-cancer early detection
glycosaminoglycans