Cell Free DNA (Cfdna) Blood Assays for the Detection of EGFR and Other Clinically Relevant Gene Mutations in Patients with Non-Small Cell Lung Cancer

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-004759
    Sponsor Protocol Number: 16-004759

About this study

The objective of this study is to validate internally developed assays for the detection of clinically relevant gene mutations in cfDNA from the peripheral blood of patients with non-small cell lung carcinoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • age 18 years or older
  • histologic evidence of non-small cell lung carcinoma
  • immediate plans for a clinically directed tumor biopsy to determine EGFR mutation status
  • new diagnosis of advanced or metastatic disease or recent progression on systemic therapy for advanced or metastatic disease
  • the absence of an active second active malignancy
  • an understanding of the protocol and its requirements, risks, and discomforts
  • the ability and willingness to sign an informed consent

Exclusion Criteria: 

  • pregnancy or lactation (for females). Pregnancy and lactation will affect cfDNA quality relative to the evaluation of tumor specific alterations. 
  • "Pregnancy (by self-report of pregnancy status)"
  • inability on the part of the patient to understand the informed consent or be compliant with the protocol

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Cassandra Nelson C.C.R.C.

(507)284-5688

Nelson.Cassandra@mayo.edu

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions