NCT02586389

Specimen Collection from Patients with Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay

Collection of Whole Blood and Tissue Specimens from Patients Diagnosed with Non-Hematologic Cancer for Use in Development of a Noninvasive Liquid Biopsy Assay to Determine the Tumor Genomic Profile in Circulating Cell-Free Tumor DNA

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Sequenom, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).

Detailed description

This is a non-significant risk multicenter, longitudinal specimen collection study. At the Baseline Visit, whole blood will be collected to be paired with either a previously collected tumor biopsy tissue sample or a prospectively collected tumor tissue sample. Whole blood samples will also be collected longitudinally at Interim visits for up to 5 years. Interim visits will be on a schedule dictated by their physician's standard-of-care management protocol. No more than 100mL of blood will be collected per month. Tumor tissue from recurrences will be collected for the duration of subject participation (after the Baseline Visit).

Conditions

• Non-hematologic Cancer

Timeline

• Start date: 2015-10-13
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2015-10-26
• Last updated: 2024-10-16

Locations

1 site across 1 country: United States