NCT05181826

Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Helio Genomics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

To acquire blood samples from subjects for various purposes, including: i) determining the sensitivity and specificity of select DNA methylation markers for the detection of various types of cancer, ii) identifying benign conditions that may induce false positive or false negative results, and iii) defining the effects of potential interfering substances, such as chemotherapy drugs.

Detailed description

Whole blood, plasma, and/or serum specimens will be collected from patients with active cancer, patients in cancer remission, patients diagnosed with benign disease, and healthy volunteers. These blood samples will be used to perform various studies to determine the utility of select DNA methylation markers for cancer diagnostic or prognostic indications.

Conditions

• Cancer
• Liver Cirrhosis
• Chronic Hepatitis
• Hepatitis B
• Hepatitis C
• Diabetes
• COPD

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multi-analyte Blood Test	Intend for the qualitative detection of DNA methylation markers for the detection of various types of cancer

Timeline

• Start date: 2019-05-21
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2022-01-06
• Last updated: 2024-06-14

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study