Circulating Tumor DNA as Liquid Biopsy in Patients With Stage IV Solid Tumors, a Feasibility Study at MUSC HCC

Completed

• Conditions: Solid Tumor, Adult
• Interventions: Procedure: research blood draws

• Registration Number: NCT03302325
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-09-29
• Study First Posted: 2017-10-05
• Study Start: 2017-10-12
• Status Verified: 2020-01
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-06
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• Age < 18-year-old

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage IV solid tumors	research blood draws	adult patients with stage IV cancer that are starting a new line of treatment

Primary Outcome Measures

Name	Time	Method
Detecting specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC.	24 months
Changes in patients' ctDNA longitudinal samples through treatment, and when available, of primary tumor and metastasis.	24 months

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States