ID

42780

Description

Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00062023

Link

https://clinicaltrials.gov/show/NCT00062023

Keywords

Versions (2)
  1. 8/4/16 8/4/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00062023

English

Eligibility Colorectal Cancer NCT00062023

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female subjects, age 40-80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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)
Description

Aberrant Crypt Foci Colorectal Quantity | Colorectal Carcinoma | Dukes staging system | Colorectal Carcinoma Tumor stage | Excision Post

Data type

boolean

Alias
UMLS CUI [1,1]
C1879526
UMLS CUI [1,2]
C0555952
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0009402
UMLS CUI [3]
C1512090
UMLS CUI [4,1]
C0009402
UMLS CUI [4,2]
C1300072
UMLS CUI [5,1]
C0728940
UMLS CUI [5,2]
C0687676
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)
Description

Aberrant Crypt Foci Colorectal Quantity | Adenoma of large intestine | Adenomatous Polyps Quantity size | Adenomatous Polyps History

Data type

boolean

Alias
UMLS CUI [1,1]
C1879526
UMLS CUI [1,2]
C0555952
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C1302401
UMLS CUI [3,1]
C0206677
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0456389
UMLS CUI [4,1]
C0206677
UMLS CUI [4,2]
C0262926
4. no elevated risk of colorectal cancer or adenomas (20 subjects)
Description

Colorectal Carcinoma Risk Elevated | Adenoma of large intestine Risk Elevated

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C3163633
UMLS CUI [2,1]
C1302401
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C3163633
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.
Description

Nasonex | Steroids Nasal Prohibited

Data type

boolean

Alias
UMLS CUI [1]
C0594492
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C1522019
UMLS CUI [2,3]
C0138547
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
Description

Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
7. no use of investigational agent(s) within the last 3 months or at the discretion of the medical monitor
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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.
Description

Laboratory Results | Hemoglobin | Platelet Count measurement | White Blood Cell Count procedure | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement

Data type

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0019046
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201913
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
Description

Patients Requirement Hormone Receptor Modulators | Tamoxifen | Arimidex

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1373075
UMLS CUI [2]
C0039286
UMLS CUI [3]
C0878174
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known diagnosis of fap, hereditary non-polyposis colon cancer (hnpcc), or inflammatory bowel disease
Description

Adenomatous Polyposis Coli | Hereditary Nonpolyposis Colorectal Neoplasms | Inflammatory Bowel Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0032580
UMLS CUI [2]
C0009405
UMLS CUI [3]
C0021390
2. history of hypersensitivity to cox-2 inhibitors, sulfonamides, nsaids , salicylates, or ursodeoxycholic acid
Description

allergy to COX-2 inhibitors | Hypersensitivity Sulfonamides | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Hypersensitivity Salicylates | Hypersensitivity Ursodiol

Data type

boolean

Alias
UMLS CUI [1]
C2136452
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0038760
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0003211
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0036077
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0042105
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.
Description

Anti-Inflammatory Agents, Non-Steroidal | Aspirin | Washout Period | Aspirin Cardiotonic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0004057
UMLS CUI [3]
C1710661
UMLS CUI [4,1]
C0004057
UMLS CUI [4,2]
C0007209
4. history of gastroduodenal ulcers documented endoscopically would preclude a patient from participation in the trial
Description

Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0030920
5. known inability to participate in the scheduled follow-up tests.
Description

Follow-up participation Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C1299582
6. significant medical or psychiatric problems which would make the patient a poor protocol candidate, in the opinion of the principal investigator.
Description

Disease Protocol Compliance Limited | Mental disorders Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
7. "unacceptable clinical risk" to proceed (based upon the subclinical discoveries made via baseline colonoscopy and biopsies).
Description

Risk Clinical Unacceptable | colonoscopy | Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C1883420
UMLS CUI [2]
C0009378
UMLS CUI [3]
C0005558
8. patient has undergone a total colectomy
Description

Total colectomy

Data type

boolean

Alias
UMLS CUI [1]
C0192871
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.
Description

Chemotherapy | Topical Chemotherapy | Therapeutic radiology procedure Pelvis | Therapeutic radiology procedure Rectum

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1519552
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0030797
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0034896
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)
Description

Invasive Carcinoma | Dukes staging system | Colorectal Carcinoma stage | Excision Post

Data type

boolean

Alias
UMLS CUI [1]
C1334274
UMLS CUI [2]
C1512090
UMLS CUI [3,1]
C0009402
UMLS CUI [3,2]
C1300072
UMLS CUI [4,1]
C0728940
UMLS CUI [4,2]
C0687676
11. patients with rectal cancer are excluded except for transanal excision without radiation.
Description

Rectal Carcinoma | transanal excision of rectal tumor | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0007113
UMLS CUI [2]
C2066010
UMLS CUI [3]
C1522449
12. patients with acute liver disease, unexplained transaminase elevations or a history of renal stones would be excluded.
Description

Acute hepatopathy | Transaminases increased Etiology unknown

Data type

boolean

Alias
UMLS CUI [1]
C3672279
UMLS CUI [2,1]
C0438717
UMLS CUI [2,2]
C0743626
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.
Description

Laboratory Results | Hemoglobin | Platelet Count measurement | White Blood Cell Count procedure | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement

Data type

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0019046
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201913
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Similar models

Eligibility Colorectal Cancer NCT00062023

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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