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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Procedure: research blood draws

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with stage IV cancer that start a new line of treatment and agree to have blood drawn

Description

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

Exclusion Criteria:

- Age < 18-year-old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Stage IV solid tumors; adult patients with stage IV cancer that are starting a new line of treatment

Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Antonio Giordano, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Actual): January 6, 2020
• Study Completion (Actual): January 6, 2020

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: stage IV solid tumor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 102718

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No