A Prospective Study of Plasma Genotyping as a Noninvasive Biomarker for Genotype-directed Cancer Care

Description

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.

Study Start Date

July 2014

Estimated Completion Date

June 2016

Interventions

No interventions cited

Specialties

  • Pulmonology: Lung/Thoracic Oncology
  • Oncology: Dermatologic Oncology,Lung/Thoracic Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Melanoma
  • NSCLC

Study ID

Dana-Farber Cancer Institute -- 14-147

Status

Unknown

Trial ID

NCT02279004

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

540

Sponsor

Dana-Farber Cancer Institute

Inclusion Criteria

  • Cohort 1: Cancers beginning initial treatment
  • One of the following diagnoses:
  • Cohort 1A: -
  • 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 (prior adjuvant therapy allowed)
  • For patients with NSCLC, EGFR and KRAS genotype may be known or unknown
  • For patients with melanoma, BRAF and NRAS genotype may be known or unknown
  • For patients without tumor genotyping, there must be a plan for genotyping including either:
  • Archived tumor tissue available and planned for genotyping
  • A biopsy at some future time is anticipated and will be available for genotyping
  • Cohort 2: Cancers with acquired resistance to targeted therapy
  • One of the following diagnoses:
  • Cohort 2A: --
  • Advanced NSCLC harboring a known EGFR mutation
  • Cohort 2B:
  • Advanced NSCLC harboring a targetable genotype other than EGFR
  • Advanced melanoma harboring a known tumor genotype
  • Clinical determination of progression targeted therapy, as evidence by plans to start a new systemic treatment regimen, or obtain a biopsy to plan a new treatment regimen
  • New systemic treatment regimen planned OR
  • Re-biopsy for resistance genotyping planned
  • Cohort 3: Cancers with a known genotype starting palliative systemic therapy Advanced NSCLC harboring one of the following mutations:
  • EGFR exon 19 deletion
  • EGFR L858R
  • EGFR T790M
  • KRAS G12X
  • BRAF V600E
  • Patients must be initiating palliative systemic therapy, either on or off a clinical trial
  • Not eligible for cohort 1 or 2

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
  • Participants with no evidence of disease
  • Participants enrolled in previous trials of targeted therapy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Adrian G Sacher MD 617-632-6796 adriang_sacher@dfci.harvard.edu

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