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

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ClinicalTrials.gov Identifier: NCT03302325
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Antonio Giordano, 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.

Condition or disease Intervention/treatment
Solid Tumor, Adult 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
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Circulating Tumor DNA as Liquid Biopsy in Patients With Stage IV Solid Tumors, a Feasibility Study at MUSC HCC
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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).




Primary Outcome Measures :
  1. Detecting specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC. [ Time Frame: 24 months ]
  2. Changes in patients' ctDNA longitudinal samples through treatment, and when available, of primary tumor and metastasis. [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
circulating tumor DNA (ctDNA) in the blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302325


Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Vistea Crawford    843-792-9321    hcc-clinical-trials@musc.edu   
Principal Investigator: Antonio Giordano, MD         
Sponsors and Collaborators
Antonio Giordano
Investigators
Principal Investigator: Antonio Giordano, MD Medical University of South Carolina

Responsible Party: Antonio Giordano, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03302325     History of Changes
Other Study ID Numbers: 102718
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Giordano, Medical University of South Carolina:
stage IV solid tumor