DNA (cfDNA) Blood Test to Detect KRAS and Other Clinically Relevant Gene Mutations in Patients with Metastatic Colorectal Cancer

Overview

About this study

KRAS gene mutations are present in approximately 40% of colorectal cancers and are known to predict for a lack of benefit from some anti-cancer medications (known as anti-EGFR antibody therapy) that are used in routine clinical practice. Currently, the only way to know if your tumor has one of these mutations is to take a tissue sample or biopsy of one of your tumors.

Unfortunately biopsies carry with them certain risks, including bleeding, infection and/or pain. This study is being done to see if a blood test can detect the KRAS mutations in the DNA circulating in the blood and be an effective method for determining if a patient’s tumor carries the mutation(s) without having to perform a biopsy.

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 colorectal carcinoma with documented or pending KRAS mutation status
  • New diagnosis of metastatic disease or recent progression on systemic therapy for metastatic disease
  • The absence of a 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)
  • 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:

Cancer Center Clinical Trials Referral Office

855-776-0015

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-20319145

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