GAGome tests for early cancer detection in healthy adults
LEVANTIS-0087A: GAGomes for Multi-Cancer Early Detection in Asymptomatic Adults (LEV87A)
This study is testing a new blood test to see if it can help find different types of cancer early in healthy adults who don’t have any symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9170 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Elypta Industry-sponsored |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05235009 on ClinicalTrials.gov |
What this trial studies
LEVANTIS-0087A (LEV87A) is a retrospective observational study aimed at validating the diagnostic performance of free GAGome-based tests for multi-cancer early detection in asymptomatic adults. The study utilizes biospecimens from population-based biobanks to assess the effectiveness of these noninvasive biomarkers in detecting various types of cancers, including those that typically shed little circulating free DNA. By comparing cancer patients with healthy controls, the study seeks to establish a reliable method for early cancer detection that could significantly reduce cancer-related mortality.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are asymptomatic for cancer and have no recent history of cancer.
Not a fit: Patients currently undergoing treatment for cancer or those with recent cancer diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a noninvasive and effective method for early cancer detection, potentially saving lives.
How similar studies have performed: Previous pilot studies have shown promising results for similar approaches using free GAGomes as biomarkers for early cancer detection.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Stockholm
- Elypta AB — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Francesco Gatto, PhD — Elypta AB
- Study coordinator: Francesco Gatto, PhD
- Email: info@elypta.com
- Phone: +46 (0)8 520 27 885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.