Age
Item
age 40 - 70 years of age.
boolean
C0001779 (UMLS CUI [1])
Criteria Quantity Fulfill
Item
history of any of the following conditions (operative notes, endoscopy reports, and/or pathology reports must be reviewed locally to confirm that the candidate meets at least one of the following entry criteria).
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Colorectal Adenoma Diameter Maximal
Item
1. colorectal adenoma(s) ≥ 1 cm in maximal diameter
boolean
C1302401 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0205289 (UMLS CUI [1,3])
Colorectal Villous Adenoma | Colorectal Tubulovillous Adenoma
Item
2. colorectal adenoma(s) with villous or tubulovillous histology
boolean
C1333119 (UMLS CUI [1])
C1333118 (UMLS CUI [2])
Colorectal Adenoma with Severe Dysplasia
Item
3. colorectal adenoma(s) with high-grade dysplasia
boolean
C1333108 (UMLS CUI [1])
Avoidance Pregnancy | Avoidance Impregnation
Item
willingness to avoid pregnancy or impregnate (see below) for the period of active study (1 year).
boolean
C0870186 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0015914 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin greater than 95% of the lower limit of institutional normal. platelets
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
≥100,000/µl.
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Blood urea nitrogen measurement | Creatinine measurement, serum
Item
ast (sgot), alt (sgpt), alkaline phosphatase, total bilirubin, bun, creatinine ≤ 1.5x upper limit of institutional normal.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0005845 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
ANA
Item
ana < 1:160
boolean
C0587178 (UMLS CUI [1])
Investigational New Drugs
Item
receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Communicable Disease | Chronic infectious disease
Item
presence of an active acute or chronic infection
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Allergic Reaction Compound Investigational New Drug Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Neoplastic Syndromes, Hereditary | FAP | HNPCC
Item
history of heritable cancer syndrome (fap, hnpcc)
boolean
C0027672 (UMLS CUI [1])
C0032580 (UMLS CUI [2])
C0009405 (UMLS CUI [3])
Autoimmune Disease | Inflammatory Bowel Disease | Lupus Erythematosus, Systemic | Rheumatoid Arthritis | Ankylosing spondylitis | Scleroderma | Multiple Sclerosis
Item
patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis.
boolean
C0004364 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
C0038013 (UMLS CUI [5])
C0011644 (UMLS CUI [6])
C0026769 (UMLS CUI [7])
Malignant Neoplasms | Exception Skin carcinoma
Item
history of malignancy < 5 years prior to the registration/randomization evaluation, excluding non-melanoma skin cancer.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Adrenal Cortex Hormones Oral
Item
any use of oral corticosteroids ≤ 12 weeks prior to registration/randomization.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Immunomodulators | Immunomodulators Planned | Remicade | Mercaptopurine | Methotrexate | Cyclosporine
Item
current or planned use of immunomodulators including: remicade, 6-mp (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs.
boolean
C1527392 (UMLS CUI [1])
C1527392 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0723012 (UMLS CUI [3])
C0000618 (UMLS CUI [4])
C0025677 (UMLS CUI [5])
C0010592 (UMLS CUI [6])
Pregnancy | Breast Feeding
Item
pregnant women, because the teratogenic or abortifacient effects of the study agents remain incompletely defined. breastfeeding women, because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])