Circulating Tumor DNA Exposure in Peripheral Blood

Study Overview
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Brief Summary
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This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).

Detailed Description
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This prospective, multi-center, feasibility study represents a feasibility study to determine the potential of circulating tumor DNA exposure in peripheral blood using a novel process in a sample of patients with different types of malignant organ tumors and a control cohort without malignant disease. The study applies a new process to detect ctDNA and other molecular markers in peripheral blood using: a collection of de-identified blood specimen and clinical data from up to 10,000 participants from clinical sites across the United States and Europe. Data collected will include the following: Demographics, Tumor Characteristics, Information about Treatment, Specimen Assessment, Postoperative Assessment Clinical information, and Follow-up at intermittent future time points, for up to 15 years. The study test(s) to be used in this protocol is a multiplexed primer and probe design developed, that allows detecting a wider set of mutations at a higher sensitivity then conventional sequencing-based method. This novel process is currently being investigated at Quantgene Inc.

Official Title
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Circulating Tumor DNA Exposure in Peripheral Blood Using a Novel Process: A Feasibility Study

Conditions
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Colorectal Cancer, Pancreatic Adenocarcinoma, Gastric Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Bladder Cancer, Melanoma, Ovarian Cancer, Adrenocortical Cancer, Breast Cancer, Other Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study will include subjects that are diagnosed with a malignancy (cohort 1) and a negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2). Subjects of both cohorts must: Be of age ≥ 18 Provide written consent for study participation Subject of cohort 1 must: Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma Subjects of cohort 2 must: • Meet the listed matching criteria Exclusion Criteria: Subjects of cohort 1 must not: Have been treated for above diagnosed malignancy Subjects of cohort 2 must not: Have been diagnosed/treated for a malignancy previously

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma Subjects of cohort 1 must not: • Have been treated for above diagnosed malignancy | |
| Cohort 2<br>Negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2). Subjects of cohort 2 must: • Meet the listed matching criteria Subjects of cohort 2 must not: • Have been diagnosed/treated for a malignancy previously | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study | The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA). | 28 Months |