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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHelio Genomics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease will eligible to participate in this study.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Multi-analyte Blood Test

    Diagnostic test

    Intend for the qualitative detection of DNA methylation markers for the detection of various types of cancer

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Independent performance measure of sensitivity and specificity of a multi-analyte blood test

The primary objective is to measure the performance (sensitivity and specificity) the multi-analyte blood Test for the detection of liver cancers in healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease.

Time frame
1 month

Secondary outcomes

1

To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test

To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test for the detection of liver cancers within healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease.

Time frame
1 Month
2

Ascertain Reference Range(s)

Ascertain reference range determination(s) for select CpG methylation sites

Time frame
1 Month
3

Ascertain Sample Stability

Sample stability under various shipping conditions

Time frame
1 Month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.