Collecting blood samples from healthy individuals and patients with cancer or benign diseases
Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer
This study is collecting blood samples from healthy people and patients with cancer or non-cancer conditions to see if certain DNA markers can help detect cancer more accurately.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helio Genomics Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Redondo Beach, California and 6 other locations) |
| Trial ID | NCT05181826 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect blood samples from healthy volunteers, patients with active cancer, patients in remission, and those with benign diseases. The samples will be analyzed to evaluate the sensitivity and specificity of certain DNA methylation markers for cancer detection. Additionally, the study will investigate benign conditions that may lead to false results and assess the impact of substances like chemotherapy drugs on these markers. The goal is to enhance the understanding of cancer diagnostics and prognostics.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of cancer, benign diseases, or those who are healthy volunteers.
Not a fit: Patients who are unwilling or unable to provide informed consent or have recently donated blood may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve cancer detection methods and reduce false positives or negatives in diagnosis.
How similar studies have performed: Other studies have shown promise in using DNA methylation markers for cancer detection, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 2.1.1 Age 18 years or older. 2.1.2 A diagnosis of cancer, cancer remission, benign disease (benign tumor, diabetes, liver cirrhosis, chronic hepatitis B or hepatitis C virus infection, Chronic obstructive pulmonary disease, etc.) or apparently healthy volunteers. . Exclusion Criteria: 2.2.1 Patients that are unwilling or unable to sign the Informed Consent Form will be excluded. 2.2.2 Approximately 50 mL of blood will be drawn from participants within an 8-week period under this protocol. Patients that have already given 50 mL of blood within this time frame will be excluded.
Where this trial is running
Redondo Beach, California and 6 other locations
- Torrance Memorial Physician Network - Cancer Care — Redondo Beach, California, United States (Active_not_recruiting)
- Allina Health, Virginia Piper Cancer Institute — Coon Rapids, Minnesota, United States (Recruiting)
- Virginia Piper Cancer Institute Mercy Hospital-Unity Campus — Fridley, Minnesota, United States (Recruiting)
- VPCI Oncology Research — Minneapolis, Minnesota, United States (Recruiting)
- Methodist LeBonheur Healthcare — Memphis, Tennessee, United States (Recruiting)
- Liver Center of Texas — Dallas, Texas, United States (Recruiting)
- Methodist Hospital — Richardson, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Operations Manager
- Email: octavia@heliogenomics.com
- Phone: 6263500537
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.