Clinical trial · Observational
LEVANTIS-0093A: GAGomes for Multi-Cancer Early Detection in High-Risk Adults (LEV93A)
- 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-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.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity and specificity of the plasma free GAGome MCED test
- timeFrame
- Within 365 days after the biosampling visit
- description
- Indicative of any-type cancer vs. no cancer diagnosis
Secondary outcomes (3)
- measure
- Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis)
- timeFrame
- Within 365 days after the biosampling visit
- description
- Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis)
- measure
- Sensitivity and specificity of the plasma free GAGome MCED test followed by low-dose computed tomography (LDCT)
- timeFrame
- Within 365 days after the biosampling visit
- description
- Indicative of any-type cancer vs. no cancer diagnosis in combination with LDCT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available