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
- To demonstrate the ability to detect specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC.
- 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|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|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|
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).
- Detecting specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC. [ Time Frame: 24 months ]
- 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
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
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Vistea Crawford 843-792-9321 firstname.lastname@example.org|
|Principal Investigator: Antonio Giordano, MD|
|Principal Investigator:||Antonio Giordano, MD||Medical University of South Carolina|