Circulating Tumor DNA As Liquid Biopsy in Patients with Stage IV Solid Tumors, a Feasibility Study At MUSC HCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-12

Study Completion Date

2020-01-06

Brief Summary

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1. To demonstrate the ability to detect specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC.
2. To compare, in each patient, ctDNA longitudinal samples through treatment, and when available, with those of primary tumor and metastasis.

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Detailed Description

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The overall goal of this study is to study circulating tumor DNA (ctDNA) in the blood to determine how cancer cells in patients react to treatment. DNA is short for deoxyribonucleic acid. DNA contains information that determines in part the traits, such as eye color, height, or disease risk, that are passed on from parent to child. This reaction will be measured by studying patient blood that will be collected before and during treatment until there is disease progression.

Conditions

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Solid Tumor, Adult

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Stage IV solid tumors

adult patients with stage IV cancer that are starting a new line of treatment

research blood draws

Intervention Type PROCEDURE

Twenty-five mL of peripheral blood (PB) will be collected for research. Blood will be collected in EDTA tubes and used to isolate ctDNA. For each subject we will request that he/she contribute 25 mL of plasma no more frequently than every 6 weeks, and at same time of standard of care blood draws and routine clinic visit, and for no more than 3 times (including baseline and end of study).

Interventions

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research blood draws

Twenty-five mL of peripheral blood (PB) will be collected for research. Blood will be collected in EDTA tubes and used to isolate ctDNA. For each subject we will request that he/she contribute 25 mL of plasma no more frequently than every 6 weeks, and at same time of standard of care blood draws and routine clinic visit, and for no more than 3 times (including baseline and end of study).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of stage IV malignancy, including any advanced solid tumors (including lymphoma)
* Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-3
* Life expectancy ≥ 3 months
* Patients must be able to provide consent
* Patients can be enrolled in other interventional clinical trials