DNA (cfDNA) Blood Test to Detect KRAS and Other Clinically Relevant Gene Mutations in Patients with Metastatic Colorectal Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
Site IRB
- Rochester, Minnesota: 14-006152
Sponsor Protocol Number: 14-006152
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 George Vasmatzis, Ph.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available