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

NCT05235009 | Recruiting

• 1 other identifier: GR 21-063
• Study Type: observational
• Target: 9,170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer

Keywords

liquid biopsy; multi-cancer early detection; glycosaminoglycans

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the combined free GAGome MCED test

  Indicative of any-type cancer vs. no cancer diagnosis

  Within 365 days after the baseline visit

Secondary Outcomes (4)

• Sensitivity and specificity of the plasma free GAGome MCED test

  Within 365 days after the baseline visit

• Sensitivity and specificity of the urine free GAGome MCED test

  Within 365 days after the baseline visit

• Accuracy to the "putative cancer location" (PCL) model in the case (cancer) arm

  Within 365 days after the baseline visit

• Overall survival (OS) in the case (cancer) arm

  From baseline visit until the date of death from any cause, assessed up to 15 years

Study Arms (2)

Sub-Study 1

Adults \>= 18 years old with cancer or imminent cancer diagnosis (cases) versus cancer-free and no imminent cancer diagnosis (controls). Sub-Study 1 is intended for the development of 3 free GAGome MCED tests.

Diagnostic Test: Combined free GAGome MCED test

Sub-Study 2

Adults between 35 - 80 years old asymptomatic for cancer and with no recent history of cancer (\> 5 years since curative-intent treatment for cancer). Sub-Study 2 is intended for the validation of the combined free GAGome MCED test (primary endpoint) and the plasma and urine free GAGome MCED tests (secondary endpoints).

Diagnostic Test: Combined free GAGome MCED test

Interventions

Combined free GAGome MCED test DIAGNOSTIC_TEST

The combined free GAGome MCED test aggregates measurements of plasma and urine GAGomes (the exhaustive human glycosaminoglycan profile) into a diagnostic score, the combined free GAGome MCED score. The measurements are performed using MIRAM MCED Kits (Elypta AB) and the scores are computed using Elypta SKY Software (Elypta AB)

Sub-Study 1; Sub-Study 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults between 35 to 80 years old asymptomatic for cancer and with no recent history of cancer.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Elypta: lead

Study Sites (1)

Elypta AB

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biobanked plasma and urine biospecimens, originally collected by the selected biobank(s).

MeSH Terms

Conditions

Neoplasms

Study Officials

• Francesco Gatto, PhD

  Elypta AB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Gatto, PhD

CONTACT

+46 (0)8 520 27 885; info@elypta.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 10, 2022
• Study Start: February 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

SE (1)