A Prospective Study of Plasma Genotyping as a Noninvasive Biomarker for Genotype-directed Cancer Care
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|ClinicalTrials.gov Identifier: NCT02279004|
Recruitment Status : Recruiting
First Posted : October 30, 2014
Last Update Posted : February 6, 2020
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||680 participants|
|Official Title:||A Prospective Study of Plasma Genotyping as a Noninvasive Biomarker for Genotype-directed Cancer Care|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Newly Diagnosed Patients
Newly diagnosed patients with advanced NSCLC or melanoma with complete or planned tissue genotyping.
Acquired Resistance Patients
NSCLC patients with a known EGFR mutation or other targetable mutation and acquired resistance to initial kinase inhibitor therapy.
Known Genotype Patients
NSCLC patients with a known genomic alteration detectable by ddPCR-based plasma genotyping and planned to start a new line of therapy.
Advanced NSCLC patients with a biopsy planned for tissue genotyping.
- Accuracy of Plasma Genotyping Assay [ Time Frame: 2 years ]We will determine the accuracy of a droplet digital PCR (ddPCR)-based plasma genotyping assay in performing noninvasive tumor genotyping.
- Turnaround Time of Plasma Genotyping Assay [ Time Frame: 2 years ]The amount of time required to perform this noninvasive genotyping assay.
- Early Treatment Failure [ Time Frame: 2 years ]The ability of serial quantitative ddPCR-based plasma genotyping to predict early treatment failure in patients initiating a new line of therapy.
- Accuracy of Plasma NGS [ Time Frame: 2 years ]We will determine the accuracy of plasma NGS in performing noninvasive genotyping compared to tumor NGS and paired ddPCR.
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): NCT02279004
|Contact: Yuebi Hufirstname.lastname@example.org|
|Contact: Ruthia Chenemail@example.com|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Yuebi Hu 617-632-4824 firstname.lastname@example.org|
|Contact: Ruthia Hu 617-632-6455 email@example.com|
|Principal Investigator: Geoffrey R Oxnard, M.D.|
|Principal Investigator:||Geoffrey R Oxnard, M.D.||Dana-Farber Cancer Institute|