A Prospective Study of Plasma Genotyping as a Noninvasive Biomarker for Genotype-directed Cancer Care
Overview
- Phase
- Not Applicable
- Intervention
- Newly Diagnosed Patients
- Conditions
- NSCLC
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 840
- Locations
- 2
- Primary Endpoint
- Accuracy of Plasma Genotyping Assay
- Status
- Active, not recruiting
- Last Updated
- 5 days ago
Overview
Brief Summary
Tumor genotyping has become an essential biomarker for the care of advanced lung cancer and melanoma, and is currently used to identify patients for treatment with targeted kinase inhibitors like erlotinib and vemurafenib. However, tumor genotyping can be slow and cumbersome, and is limited by availability of tumor biopsy tissue for testing. The aim of this study is to prospectively evaluate a blood-based genotyping tool that can quantify the presence of oncogenic mutations (EGFR, KRAS, BRAF) in patients with lung cancer and melanoma. This assay is being studied both as a diagnostic tool for classifying patient genotype, and a serial measurement tool for quantification of response and progression on therapy.
Investigators
Julia K. Rotow, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •To participate in this study a participant must meet the eligibility of one of the following cohorts:
- •Cohort 1: Cancers beginning initial treatment
- •One of the following diagnoses:
- •Cohort 1A (CLOSED):
- •--Advanced non-squamous NSCLC (including adenosquamous)
- •Cohort 1B:
- •Stage II-III non-squamous NSCLC (including adenosquamous)
- •Stage IIIB-IV melanoma
- •Patient must be planned to begin initial therapy, or completely resected before or after receiving adjuvant therapy
- •For patients with NSCLC, EGFR and KRAS genotype may be known or unknown
Exclusion Criteria
- •Participants who are unable to provide informed consent
- •Participants who are 18 years of age or younger
- •Participants who are unable to comply with the study procedures
Arms & Interventions
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
Advanced NSCLC patients with a biopsy planned for tissue genotyping.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Turnaround Time of Plasma Genotyping Assay(2 years)
- Early Treatment Failure(2 years)
- Accuracy of Plasma NGS(2 years)