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

NCT03302325 | Completed DMC

• 1 other identifier: 102718
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor, Adult

Keywords

stage IV solid tumor

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Stage IV solid tumors

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

Procedure: research blood draws

Interventions

research blood draws 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).

Stage IV solid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- Age \< 18-year-old

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

circulating tumor DNA (ctDNA) in the blood

Study Officials

• Antonio Giordano, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: October 5, 2017
• Study Start: October 12, 2017
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)