ID

28146

Description

DNA Changes That Affect Vitamin D Metabolism in Patients With Colorectal Cancer Receiving Vitamin D Supplements; ODM derived from: https://clinicaltrials.gov/show/NCT00550563

Link

https://clinicaltrials.gov/show/NCT00550563

Keywords

Versions (1)
  1. 12/21/17 12/21/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00550563

English

Eligibility Colorectal Cancer NCT00550563

1 forms  
Criteria
Description

Criteria

prior or current documented diagnosis of colorectal cancer
Description

Colorectal Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0009402
all stages
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
25oh-d3 level < 50 ng/ml
Description

Calcifediol

Data type

boolean

Alias
UMLS CUI [1]
C0006657
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
serum creatinine < 2.0 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
serum bilirubin < 2.0 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
no prior or current hypercalcemia (defined as albumin corrected serum calcium < 10.2 mg/dl)
Description

Hypercalcemia Absent | Serum Calcium Level Corrected for albumin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0036785
UMLS CUI [2,2]
C1439360
no known contraindication for vitamin d supplementation
Description

Absence Medical contraindication Vitamin D supplement

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C3541352
no genitourinary stones within the past 5 years
Description

Absence Calculi Genitourinary

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0006736
UMLS CUI [1,3]
C3887515
no severe comorbid conditions such as uncompensated heart failure or active infection
Description

Absence Comorbidity Severe | Decompensated cardiac failure Absent | Communicable Disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009488
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0581377
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0332197
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
no supplemental vitamin d beyond what is provided through the study
Description

Vitamin D supplement Absent | Exception Vitamin D supplement Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C3541352
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3541352
UMLS CUI [2,3]
C2348563
at least 2 months since prior vitamin d supplementation exceeding 800 international units (iu)
Description

Time period Since Vitamin D supplement IU/day

Data type

boolean

Alias
UMLS CUI [1,1]
C1948053
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C3541352
UMLS CUI [1,4]
C0439465
nondietary vitamin d supplements should not have exceeded 800 iu/day within the past 2 months
Description

Vitamin D supplement IU/day Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C3541352
UMLS CUI [1,2]
C0439465
UMLS CUI [1,3]
C0439801
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Similar models

Eligibility Colorectal Cancer NCT00550563

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Colorectal Carcinoma
Item
prior or current documented diagnosis of colorectal cancer
boolean
C0009402 (UMLS CUI [1])
TNM clinical staging
Item
all stages
boolean
C3258246 (UMLS CUI [1])
Calcifediol
Item
25oh-d3 level < 50 ng/ml
boolean
C0006657 (UMLS CUI [1])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin < 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Hypercalcemia Absent | Serum Calcium Level Corrected for albumin
Item
no prior or current hypercalcemia (defined as albumin corrected serum calcium < 10.2 mg/dl)
boolean
C0020437 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0036785 (UMLS CUI [2,1])
C1439360 (UMLS CUI [2,2])
Absence Medical contraindication Vitamin D supplement
Item
no known contraindication for vitamin d supplementation
boolean
C0332197 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C3541352 (UMLS CUI [1,3])
Absence Calculi Genitourinary
Item
no genitourinary stones within the past 5 years
boolean
C0332197 (UMLS CUI [1,1])
C0006736 (UMLS CUI [1,2])
C3887515 (UMLS CUI [1,3])
Absence Comorbidity Severe | Decompensated cardiac failure Absent | Communicable Disease Absent
Item
no severe comorbid conditions such as uncompensated heart failure or active infection
boolean
C0332197 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0581377 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Vitamin D supplement Absent | Exception Vitamin D supplement Study Protocol
Item
no supplemental vitamin d beyond what is provided through the study
boolean
C3541352 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C3541352 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Time period Since Vitamin D supplement IU/day
Item
at least 2 months since prior vitamin d supplementation exceeding 800 international units (iu)
boolean
C1948053 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C3541352 (UMLS CUI [1,3])
C0439465 (UMLS CUI [1,4])
Vitamin D supplement IU/day Limited
Item
nondietary vitamin d supplements should not have exceeded 800 iu/day within the past 2 months
boolean
C3541352 (UMLS CUI [1,1])
C0439465 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
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