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

Launched by ELYPTA · Feb 9, 2022

Keywords

ClinConnect Summary

The LEVANTIS-0087A trial is studying a new test designed to detect multiple types of cancer early in adults who do not have any symptoms and have not recently been diagnosed with cancer. The aim is to see how effectively this test can identify cancer in people who are currently healthy. To participate, you must be over 18 years old and provide urine and blood samples. If you have been diagnosed with cancer in the past, it should have been treated at least five years ago, and you shouldn't be currently undergoing treatment or monitoring for cancer.

Participants in this study can expect to provide samples and complete some questionnaires during the trial. It’s important to note that this study is still recruiting, meaning they are looking for volunteers to join. If you meet the eligibility criteria, this could be an opportunity to help advance early cancer detection methods that may benefit many people in the future.

Gender

ALL

Eligibility 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.