ID

16813

Description

Celebrex With Preoperative Chemoradiation - Rectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00188565

Link

https://clinicaltrials.gov/show/NCT00188565

Keywords

  1. 8/8/16 8/8/16 -
Uploaded on

August 8, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Colorectal Neoplasms NCT00188565

Eligibility Colorectal Neoplasms NCT00188565

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with resectable or potentially resectable adenocarcinoma of the rectum
Description

Adenocarcinoma of rectum Resectable | Adenocarcinoma of rectum Resectable potential

Data type

boolean

Alias
UMLS CUI [1,1]
C0149978
UMLS CUI [1,2]
C1514888
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1514888
UMLS CUI [2,3]
C3245505
clinical stage t2 n1-2 or t3-4 n0-2 (patients who require diverting loop colostomy are eligible)
Description

TNM clinical staging | Loop colostomy - stoma Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0444911
UMLS CUI [2,2]
C0686904
age greater than 18 years, ecog performance status < 2 (appendix, section 13.1)
Description

Age | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy
Description

Adenocarcinoma | Biopsy | Tumor margin Upper Distance from anal verge | Rigid sigmoidoscopy

Data type

boolean

Alias
UMLS CUI [1]
C0001418
UMLS CUI [2]
C0005558
UMLS CUI [3,1]
C1269830
UMLS CUI [3,2]
C1282910
UMLS CUI [3,3]
C1317308
UMLS CUI [4]
C0399626
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
distant metastasis, prior pelvic irradiation, inflammatory bowel disease, medical conditions which preclude radical therapy
Description

distant metastasis | irradiation of pelvis | Inflammatory Bowel Diseases | medical condition Exclusion Radical therapy

Data type

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2]
C0747411
UMLS CUI [3]
C0021390
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C2828389
UMLS CUI [4,3]
C0260176
history of malignancy within five years (except nonmelanoma skin cancer, cin cervix)
Description

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
hypersensitivity to celecoxib, nsaid, sulfonamides or 5-fu
Description

Hypersensitivity celecoxib | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Hypersensitivity Sulfonamides | Hypersensitivity Fluorouracil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0538927
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003211
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0038760
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0016360
significant comorbid illness
Description

Comorbidity Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
history of peptic ulcer disease or nsaid-related gastrointestinal bleeding
Description

Peptic Ulcer | Gastrointestinal Hemorrhage NSAID Related

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2,1]
C0017181
UMLS CUI [2,2]
C0003211
UMLS CUI [2,3]
C0439849
use of aspirin, other nsaid or coxib in the two weeks prior to study entry
Description

Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C0003211
UMLS CUI [3]
C1257954
neutrophil count <1.5x109/l, platelet count <100x109/l, serum bilirubin >1.25xuln (upper limit of normal), ast/alt >3xuln, serum creatinine >1.25xuln
Description

Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201976

Similar models

Eligibility Colorectal Neoplasms NCT00188565

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of rectum Resectable | Adenocarcinoma of rectum Resectable potential
Item
patients with resectable or potentially resectable adenocarcinoma of the rectum
boolean
C0149978 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0149978 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
C3245505 (UMLS CUI [2,3])
TNM clinical staging | Loop colostomy - stoma Patient need for
Item
clinical stage t2 n1-2 or t3-4 n0-2 (patients who require diverting loop colostomy are eligible)
boolean
C3258246 (UMLS CUI [1])
C0444911 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Age | ECOG performance status
Item
age greater than 18 years, ecog performance status < 2 (appendix, section 13.1)
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Adenocarcinoma | Biopsy | Tumor margin Upper Distance from anal verge | Rigid sigmoidoscopy
Item
biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy
boolean
C0001418 (UMLS CUI [1])
C0005558 (UMLS CUI [2])
C1269830 (UMLS CUI [3,1])
C1282910 (UMLS CUI [3,2])
C1317308 (UMLS CUI [3,3])
C0399626 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
distant metastasis | irradiation of pelvis | Inflammatory Bowel Diseases | medical condition Exclusion Radical therapy
Item
distant metastasis, prior pelvic irradiation, inflammatory bowel disease, medical conditions which preclude radical therapy
boolean
C1269798 (UMLS CUI [1])
C0747411 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
C3843040 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
C0260176 (UMLS CUI [4,3])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
history of malignancy within five years (except nonmelanoma skin cancer, cin cervix)
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity celecoxib | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Hypersensitivity Sulfonamides | Hypersensitivity Fluorouracil
Item
hypersensitivity to celecoxib, nsaid, sulfonamides or 5-fu
boolean
C0020517 (UMLS CUI [1,1])
C0538927 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0038760 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0016360 (UMLS CUI [4,2])
Comorbidity Significant
Item
significant comorbid illness
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Peptic Ulcer | Gastrointestinal Hemorrhage NSAID Related
Item
history of peptic ulcer disease or nsaid-related gastrointestinal bleeding
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors
Item
use of aspirin, other nsaid or coxib in the two weeks prior to study entry
boolean
C0004057 (UMLS CUI [1])
C0003211 (UMLS CUI [2])
C1257954 (UMLS CUI [3])
Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum
Item
neutrophil count <1.5x109/l, platelet count <100x109/l, serum bilirubin >1.25xuln (upper limit of normal), ast/alt >3xuln, serum creatinine >1.25xuln
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201976 (UMLS CUI [6])

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