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

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Closed for enrollment

Contact information:

Vicki Clark CCRP

(507) 293-7833

Clark.Vicki@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20306559

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