Specimen Collection From Patients With Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay

Study Overview
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Brief Summary
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This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).

Detailed Description
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This is a non-significant risk multicenter, longitudinal specimen collection study. At the Baseline Visit, whole blood will be collected to be paired with either a previously collected tumor biopsy tissue sample or a prospectively collected tumor tissue sample. Whole blood samples will also be collected longitudinally at Interim visits for up to 5 years. Interim visits will be on a schedule dictated by their physician's standard-of-care management protocol. No more than 100mL of blood will be collected per month. Tumor tissue from recurrences will be collected for the duration of subject participation (after the Baseline Visit).

Official Title
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Collection of Whole Blood and Tissue Specimens From Patients Diagnosed With Non-Hematologic Cancer for Use in Development of a Noninvasive Liquid Biopsy Assay to Determine the Tumor Genomic Profile in Circulating Cell-Free Tumor DNA

Conditions
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Non-hematologic Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age or older; Subject is willing to provide written informed consent; Subject has a diagnosis of a non-hematologic cancer, has tumor in the body, and has either; residual tumor tissue available for testing by the Sponsor; or genomic profiling results from an IVD or LDT assay performed on tumor biopsy tissue; or an invasive procedure (biopsy, surgery) scheduled following the Baseline Visit from which residual tumor tissue can be available for testing by the Sponsor. Subject is able, in the professional opinion of the investigator, to provide whole blood at the Baseline Visit and at the Interim Visits. Exclusion Criteria: Underwent curative-intent surgery for management of the presently diagnosed tumor, at any time prior to the Baseline Visit. Underwent targeted or non-targeted chemotherapy, hormone receptor blocking therapy, or radiation therapy prior to the Baseline Visit. Underwent an invasive procedure (biopsy, surgery, thermal ablation) in the 7 days prior to any blood collection (baseline or follow-up). Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-hematological Cancer Cohort<br>Eligible subjects will have been previously diagnosed with a non-hematological cancer with tumor present at baseline blood draw. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biospecimen sample collection for liquid biopsy assay development | Analysis of circulating tumor DNA (ctDNA) in whole blood will be compared to baseline tumor DNA for concordance of mutations related to cancer. | After cancer diagnosis through 5 years of standard of care follow-up visits |