Age
Item
1. male or female subjects, age 40-80 years
boolean
C0001779 (UMLS CUI [1])
Aberrant Crypt Foci Colorectal Quantity | Colorectal Carcinoma | Dukes staging system | Colorectal Carcinoma Tumor stage | Excision Post
Item
2. with >5 colorectal acf and a prior history of colorectal cancer defined as dukes a/b1 carcinoma within 5 years of entry or any stage of colorectal cancer if at least 5 years post surgical resection (86 subjects)
boolean
C1879526 (UMLS CUI [1,1])
C0555952 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0009402 (UMLS CUI [2])
C1512090 (UMLS CUI [3])
C0009402 (UMLS CUI [4,1])
C1300072 (UMLS CUI [4,2])
C0728940 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
Aberrant Crypt Foci Colorectal Quantity | Adenoma of large intestine | Adenomatous Polyps Quantity size | Adenomatous Polyps History
Item
3. with >5 colorectal acf and recent/current history of colorectal adenoma(s) defined as one of the following: one adenomatous polyp >1cm or two or more adenomatous polyps of any size or one adenomatous polyp of any size and a documented history of adenomatous polyp(s) (86 subjects)
boolean
C1879526 (UMLS CUI [1,1])
C0555952 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1302401 (UMLS CUI [2])
C0206677 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0456389 (UMLS CUI [3,3])
C0206677 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
Colorectal Carcinoma Risk Elevated | Adenoma of large intestine Risk Elevated
Item
4. no elevated risk of colorectal cancer or adenomas (20 subjects)
boolean
C0009402 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C3163633 (UMLS CUI [1,3])
C1302401 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C3163633 (UMLS CUI [2,3])
Nasonex | Steroids Nasal Prohibited
Item
5. subjects will be permitted to use nasonex but all other nasal steroids are prohibited. subjects may change to nasonex but must have discontinued previous nasal steroid use for at least 30 days prior to study randomization.
boolean
C0594492 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C1522019 (UMLS CUI [2,2])
C0138547 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative
Item
6. if participant is female and of childbearing potential, she must agree to use adequate contraception and must have a negative serum pregnancy test within 14 days prior to study drug administration
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Investigational New Drugs
Item
7. no use of investigational agent(s) within the last 3 months or at the discretion of the medical monitor
boolean
C0013230 (UMLS CUI [1])
Laboratory Results | Hemoglobin | Platelet Count measurement | White Blood Cell Count procedure | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement
Item
8. the subject will be allowed to proceed to randomization so long as all of the following laboratory criteria are met on baseline evaluation: hgb > 10.0 g/dl, platelet count > 100,000/ul; wbc > 3,000/ul; alt < 2 x upper limit of normal; ast < 2 x upper limit of normal, and total bilirubin <1.5mg/100ml.
boolean
C1254595 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201913 (UMLS CUI [7])
Patients Requirement Hormone Receptor Modulators | Tamoxifen | Arimidex
Item
9. patients requiring use of hormone modulators such as tamoxifen or arimidex will be permitted to enroll providing they meet all of the eligibility criteria noted above
boolean
C0030705 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1373075 (UMLS CUI [1,3])
C0039286 (UMLS CUI [2])
C0878174 (UMLS CUI [3])
Adenomatous Polyposis Coli | Hereditary Nonpolyposis Colorectal Neoplasms | Inflammatory Bowel Diseases
Item
1. known diagnosis of fap, hereditary non-polyposis colon cancer (hnpcc), or inflammatory bowel disease
boolean
C0032580 (UMLS CUI [1])
C0009405 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
allergy to COX-2 inhibitors | Hypersensitivity Sulfonamides | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Hypersensitivity Salicylates | Hypersensitivity Ursodiol
Item
2. history of hypersensitivity to cox-2 inhibitors, sulfonamides, nsaids , salicylates, or ursodeoxycholic acid
boolean
C2136452 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0038760 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0003211 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0036077 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0042105 (UMLS CUI [5,2])
Anti-Inflammatory Agents, Non-Steroidal | Aspirin | Washout Period | Aspirin Cardiotonic Agents
Item
3. use of nsaids, including aspirin, at any dose during the six months prior to study entry will require a three month washout period prior to eligibility beginning with the time of the last dose. participants must be off all nsaids for three months prior to study entry. individuals on cardioprotectant aspirin at any dose will not be eligible.
boolean
C0003211 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C1710661 (UMLS CUI [3])
C0004057 (UMLS CUI [4,1])
C0007209 (UMLS CUI [4,2])
Peptic Ulcer
Item
4. history of gastroduodenal ulcers documented endoscopically would preclude a patient from participation in the trial
boolean
C0030920 (UMLS CUI [1])
Follow-up participation Unable
Item
5. known inability to participate in the scheduled follow-up tests.
boolean
C3274571 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Disease Protocol Compliance Limited | Mental disorders Protocol Compliance Limited
Item
6. significant medical or psychiatric problems which would make the patient a poor protocol candidate, in the opinion of the principal investigator.
boolean
C0012634 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Risk Clinical Unacceptable | colonoscopy | Biopsy
Item
7. "unacceptable clinical risk" to proceed (based upon the subclinical discoveries made via baseline colonoscopy and biopsies).
boolean
C0035647 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1883420 (UMLS CUI [1,3])
C0009378 (UMLS CUI [2])
C0005558 (UMLS CUI [3])
Total colectomy
Item
8. patient has undergone a total colectomy
boolean
C0192871 (UMLS CUI [1])
Chemotherapy | Topical Chemotherapy | Therapeutic radiology procedure Pelvis | Therapeutic radiology procedure Rectum
Item
9. patient has received chemotherapy within the past 6 months of randomization into study. topical chemotherapy will be assessed on a case-by-case basis. any history of pelvic or rectal radiation therapy will exclude a patient from participating.
boolean
C0392920 (UMLS CUI [1])
C1519552 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0030797 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0034896 (UMLS CUI [4,2])
Invasive Carcinoma | Dukes staging system | Colorectal Carcinoma stage | Excision Post
Item
10. history of invasive carcinoma in the past five years (except patients with dukes a/b1 carcinoma within 5 years of entry or any stage of colorectal cancer if at least 5 years post surgical resection)
boolean
C1334274 (UMLS CUI [1])
C1512090 (UMLS CUI [2])
C0009402 (UMLS CUI [3,1])
C1300072 (UMLS CUI [3,2])
C0728940 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
Rectal Carcinoma | transanal excision of rectal tumor | Therapeutic radiology procedure
Item
11. patients with rectal cancer are excluded except for transanal excision without radiation.
boolean
C0007113 (UMLS CUI [1])
C2066010 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Acute hepatopathy | Transaminases increased Etiology unknown
Item
12. patients with acute liver disease, unexplained transaminase elevations or a history of renal stones would be excluded.
boolean
C3672279 (UMLS CUI [1])
C0438717 (UMLS CUI [2,1])
C0743626 (UMLS CUI [2,2])
Laboratory Results | Hemoglobin | Platelet Count measurement | White Blood Cell Count procedure | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement
Item
13. participants will not be permitted to be randomized into the trial if any of the following laboratory values are reported at baseline : hgb < 10.0 g/dl, platelet count <100,000/ul; wbc < 3,000/ul; alt > 2 x upper limit of normal; ast > 2 x upper limit of normal, and total bilirubin >1.5mg/100ml.
boolean
C1254595 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201913 (UMLS CUI [7])