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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03302325

Enrollment

Registered

2017-10-05

Start date

2017-10-12

Completion date

2020-01-06

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor, Adult

Keywords

stage IV solid tumor

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.

Interventions

PROCEDUREresearch 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).

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026