Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multi-analyte Blood Test.
- Who it may be relevant to
- Registry conditions: Cancer, Liver Cirrhosis, Chronic Hepatitis, Hepatitis B. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test Multi-analyte Blood Test
Intend for the qualitative detection of DNA methylation markers for the detection of various types of cancer
Primary outcome measures
- Independent performance measure of sensitivity and specificity of a multi-analyte blood test [Time frame: 1 month]
Secondary outcome measures (3)
- To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test [Time frame: 1 Month]
- Ascertain Reference Range(s) [Time frame: 1 Month]
- Ascertain Sample Stability [Time frame: 1 Month]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
United States · 7 centers
- Torrance Memorial Physician Network - Cancer Care — Redondo Beach
- Allina Health, Virginia Piper Cancer Institute — Coon Rapids
- Virginia Piper Cancer Institute Mercy Hospital-Unity Campus — Fridley
- VPCI Oncology Research — Minneapolis
- Methodist LeBonheur Healthcare — Memphis
- Liver Center of Texas — Dallas
- Methodist Hospital — Richardson
Identifiers
NCT: NCT05181826 · 001-2018