Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:Subjects may participate in this study if all of the following criteria apply: 1. Provide written informed consent. 2. Male or female ages 18 or older. 3. Evidence of cancer of the colon or rectum that is metastatic to the liver. NOTE: patients may enroll prior to receiving clinical biopsy results. If they are not confirmed to have adenocarcinoma of the colon or rectum that is metastatic to the liver, they will not be evaluable. 4. Treating physician planning to treat CRC liver metastasis with a standard of care therapy. 5. Previous adjuvant or neoadjuvant therapies allowed. 6. Biopsy may be obtained prior to starting the 2nd cycle of a new standard of care therapy. 7. Measurable disease as measured by RECIST 1.1 criteria. 8. Life expectancy of ≥ 12 weeks. 9. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2. 10 Adequate coagulation function as evidenced by: 1. Absolute neutrophil count ≥ 1.0 x 109/L. 2. Platelets ≥ 50 x 109/L. 3. Hemoglobin >= 8 g/dL (transfusions are permitted to achieve baseline hemoglobin level) 4. ALT/AST (alanine aminotransferase (ALT) / aspartate aminotransferase (AST)) < 2.5 x upper limit of normal (ULN); or < 5 x ULN in the presence of liver metastases. 5. Total bilirubin < 1.5 x ULN (if total bilirubin >= 1.5 x ULN then the subject may participate if the direct bilirubin is ≤ 1.5 x ULN) 6. Creatinine clearance > 30 mL/min measured or calculated by Cockcroft-Gault equation or the estimated glomerular filtration rate (GFR) > 30 mL/min/1.73 m2 using the MDRD. 7. INR<1.5.
Exclusion Criteria:Subjects may not participate if any of the following criteria apply: 1. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment. 2. Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from day 1 of start of therapy, New York Heart Association Class II, III or IV congestive heart failure, and arrhythmia requiring therapy. 3. Presence of significant concurrent, uncontrolled medical condition including but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, active infection, non-healing wound, or psychiatric disease that excludes them from receiving chemotherapy. 4. Pregnant or actively breastfeeding women (Pregnant or breastfeeding women are not candidates for chemotherapy).
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
The purpose of this study is to assess the feasibility of creating patient derived models of cancer (i.e., MOS) from patients with colorectal cancer liver metastasis. The investigators of this study focus on a precision medicine strategy for patients with CRC liver metastasis. Participating subjects will undergo biopsy of patient's liver lesion and the diagnosis of CRC liver metastasis will be verified by pathology. Patients will be treated with standard of care therapy determined by the treating physician. As part of standard of care therapy, patients will undergo lab work including CEA (carcinoembryonic antigen) and CT of the chest, abdomen and pelvis for staging and measurement of tumor size every two months. Up to 250 patients will be enrolled to the study. Enrolled subjects are defined as subjects who give informed consent. Screen failures are defined as subjects who give informed consent and do not meet eligibility criteria. Accrued subjects are defined as subjects who give informed consent and meet eligibility criteria. Evaluable subjects are defined as those who accrue, receive the study biopsy and have cytologically or histologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver. If the biopsy tissue is not confirmed to be adenocarcinoma of the colon or rectum, the subject will be considered non-evaluable and will be replaced. MOS will be generated from the study biopsy and a drug screen will be performed to determine sensitivity to standard of care therapy. This method has been proven to have a 75% success rate of generating MOS and testing sensitivity to standard of care therapy from tumor biopsy samples.
: CRC Standard of Care
Colorectal patients with confirmed liver metastasis that has have submitted tumor biopsy sample and receive standard of care therapy.
Other: - No intervention for this trial.
The patient will receive standard of care dictated by the treating physician.