Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Academic and Community Cancer Research United
With
National Cancer Institute (NCI)
PRIMARY OBJECTIVES:
I. To perform blood-based genomic profiling on patients with treatment refractory metastatic colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies.
II. To facilitate clinically annotated genomic analyses.
OUTLINE:
Patients submit blood samples for genetic testing.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histological confirmation of adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
Progression, intolerance, or contraindication to a fluoropyrimidine (e.g., 5- fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ziv-aflibercept, or ramucirumab), and an anti-PD-1 monoclonal antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability-high (MSI-H)
For patients with KRAS and NRAS wild-type tumors, progression, intolerance, or contraindication to an anti-EGFR monoclonal antibody (cetuximab or panitumumab)
* Note: If tissue is known to be positive for HER2 expression (IHC 3+) or the tumor has ERBB2 (HER2) amplification detected by a Clinical Laboratory Improvement Act (CLIA)-certified assay, prior treatment with anti-EGFR therapy is not required
At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
Life expectancy \>= 3 months per estimation of investigator
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Capable of understanding and complying with the protocol requirements and has signed the informed consent document
Satisfy at least one of the following two conditions:
* Willing and able to provide blood sample for screening purposes
* Guardant 360 testing completed =\< 60 days prior to registration
You may not be if
Evidence within the last 3 years of another malignancy which required systemic treatment. EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or localized prostate cancer with a current PSA of \< 1.0mg/dL on 2 successive evaluations, at least 90 days apart, with the most recent evaluation no more than 4 weeks prior to registration
Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
History of solid organ transplantation
Pregnant or planning to become pregnant within the next 12 months
