ID

26643

Beskrivning

Breath Test for Women Receiving Tamoxifen in the Prevention or Treatment of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00873366

Länk

https://clinicaltrials.gov/show/NCT00873366

Nyckelord

Versioner (2)
  1. 2017-10-23 2017-10-23 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 oktober 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00873366

Engelsk

Eligibility Breast Cancer NCT00873366

1 Formulär  
Criteria
Beskrivning

Criteria

eligible to receive tamoxifen for 6 months for either the prevention or treatment of non-invasive or invasive, stage i-iii breast cancer
Beskrivning

Tamoxifen | Prophylactic treatment Breast Carcinoma TNM Breast tumor staging | Prophylactic treatment Invasive carcinoma of breast TNM Breast tumor staging | Therapeutic procedure Breast Carcinoma TNM Breast tumor staging | Therapeutic procedure Invasive carcinoma of breast TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2,1]
C0199176
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0474926
UMLS CUI [3,1]
C0199176
UMLS CUI [3,2]
C0853879
UMLS CUI [3,3]
C0474926
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0678222
UMLS CUI [4,3]
C0474926
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0853879
UMLS CUI [5,3]
C0474926
cyp2d6 genotype known
Beskrivning

CYP2D6 gene Known

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1332830
UMLS CUI [1,2]
C0205309
patients determined to be cyp2d6 poor metabolizers (by determination of a genotype test by their mayo physician prior to study registration) are eligible to proceed with the initial breath test only
Beskrivning

CYP2D6 gene Poor metabolizer | cytochrome p450 2D6 genotype | Breath Test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1332830
UMLS CUI [1,2]
C3845231
UMLS CUI [2]
C2164095
UMLS CUI [3]
C0006153
hormone receptor status not specified
Beskrivning

Hormone Receptor Status Unspecified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Beskrivning

Client Characteristics

Datatyp

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Beskrivning

Menopausal Status Unspecified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513126
UMLS CUI [1,2]
C0205370
ecog performance status 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

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

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
no known impaired hepatic activity defined as ≥ grade 3 ast, alkaline phosphatase, or total bilirubin
Beskrivning

Exclusion Liver Dysfunction Grade | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0086565
UMLS CUI [1,3]
C0441800
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201850
UMLS CUI [4]
C1278039
no pulmonary disease (e.g., asthma or other respiratory disease) associated with hypercapnia
Beskrivning

Exclusion Criteria | Lung disease Associated with Hypercapnia | Asthma | Respiration Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0020440
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0035204
no uncontrolled metabolic disease (e.g., diabetes in the presence of gastroparesis, uncontrolled congestive heart failure, or uncontrolled gastrointestinal disorders [e.g., gerd])
Beskrivning

Exclusion Criteria | Metabolic Diseases Uncontrolled | Gastroparesis due to diabetes mellitus | Congestive heart failure Uncontrolled | Gastrointestinal Diseases Uncontrolled | Gastroesophageal reflux disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0025517
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0267176
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0017178
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0017168
no prior adverse reaction to dextromethorphan
Beskrivning

Exclusion Adverse reactions Dextromethorphan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0559546
UMLS CUI [1,3]
C0011816
no history of chronic liver disease (e.g., hepatitis b or hepatitis c, alcoholic liver disease, cirrhosis, or fibrotic disease)
Beskrivning

Exclusion Criteria | Chronic liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic | Chronic alcoholic liver disease | Liver Cirrhosis chronic | Chronic fibrosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0341439
UMLS CUI [3]
C0524909
UMLS CUI [4]
C0524910
UMLS CUI [5]
C4076349
UMLS CUI [6,1]
C0023890
UMLS CUI [6,2]
C0205191
UMLS CUI [7]
C0334133
able and willing to fast overnight prior to the study session
Beskrivning

Fasting Overnight Able | Fasting Overnight Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C0439583
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0015663
UMLS CUI [2,2]
C0439583
UMLS CUI [2,3]
C0600109
willing to return to mayo clinic for follow-up
Beskrivning

Follow-up Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0600109
willing to provide biologic specimens
Beskrivning

Biospecimen Provide Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347026
UMLS CUI [1,2]
C1999230
UMLS CUI [1,3]
C0600109
prior concurrent therapy:
Beskrivning

Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
more than 24 hours since prior medications known to slow gastric emptying or gastrointestinal motility (e.g., alcohol, opioid analgesics, anticholinergics [e.g., antihistamines], and loperamide)
Beskrivning

Pharmaceutical Preparations Previous Slowing Gastric Emptying | Pharmaceutical Preparations Previous Slowing Gastrointestinal Motility | Alcohol | Analgesics, Opioid | Anticholinergic Agents | Antihistamines | Loperamide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0439834
UMLS CUI [1,4]
C0017127
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0439834
UMLS CUI [2,4]
C0017184
UMLS CUI [3]
C0001975
UMLS CUI [4]
C0002772
UMLS CUI [5]
C0242896
UMLS CUI [6]
C0003360
UMLS CUI [7]
C0023992
UMLS CUI [8]
C0162373
more than 4 weeks since prior and no concurrent cyp2d6 inhibitors or concurrent serotonin-reuptake inhibitors known to be potent cyp2d6 inhibitors (e.g.,paroxetine [paxil®] and fluoxetine [prozac®]
Beskrivning

CYP2D6 Inhibitors Previous | Selective Serotonin Reuptake Inhibitors Previous | Paroxetine | Paxil | Fluoxetine | Prozac

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3850058
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0360105
UMLS CUI [2,2]
C0205156
UMLS CUI [3]
C0070122
UMLS CUI [4]
C0376414
UMLS CUI [5]
C0016365
UMLS CUI [6]
C0162373
if mild to moderate inhibitors of cyp2d6 are medically necessary, patients may go back on after the 8-week time point
Beskrivning

CYP2D6 Inhibitors Mild Patient need for | CYP2D6 Inhibitors Moderate Patient need for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3850058
UMLS CUI [1,2]
C2945599
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C3850058
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C0686904
more than 4 weeks since prior and no concurrent monoamine-oxidase inhibitors (e.g., furazolidone, phenelzine, procarbazine, selegiline, and tranylcypromine)
Beskrivning

Monoamine Oxidase Inhibitors Previous | Furazolidone | Phenelzine | Procarbazine | Selegiline | Tranylcypromine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026457
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0016855
UMLS CUI [3]
C0031392
UMLS CUI [4]
C0033223
UMLS CUI [5]
C0036579
UMLS CUI [6]
C0040778
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Similar models

Eligibility Breast Cancer NCT00873366

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Tamoxifen | Prophylactic treatment Breast Carcinoma TNM Breast tumor staging | Prophylactic treatment Invasive carcinoma of breast TNM Breast tumor staging | Therapeutic procedure Breast Carcinoma TNM Breast tumor staging | Therapeutic procedure Invasive carcinoma of breast TNM Breast tumor staging
Item
eligible to receive tamoxifen for 6 months for either the prevention or treatment of non-invasive or invasive, stage i-iii breast cancer
boolean
C0039286 (UMLS CUI [1])
C0199176 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0199176 (UMLS CUI [3,1])
C0853879 (UMLS CUI [3,2])
C0474926 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0474926 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C0853879 (UMLS CUI [5,2])
C0474926 (UMLS CUI [5,3])
CYP2D6 gene Known
Item
cyp2d6 genotype known
boolean
C1332830 (UMLS CUI [1,1])
C0205309 (UMLS CUI [1,2])
CYP2D6 gene Poor metabolizer | cytochrome p450 2D6 genotype | Breath Test
Item
patients determined to be cyp2d6 poor metabolizers (by determination of a genotype test by their mayo physician prior to study registration) are eligible to proceed with the initial breath test only
boolean
C1332830 (UMLS CUI [1,1])
C3845231 (UMLS CUI [1,2])
C2164095 (UMLS CUI [2])
C0006153 (UMLS CUI [3])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C1513126 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
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])
Exclusion Liver Dysfunction Grade | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement
Item
no known impaired hepatic activity defined as ≥ grade 3 ast, alkaline phosphatase, or total bilirubin
boolean
C2828389 (UMLS CUI [1,1])
C0086565 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0201899 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Exclusion Criteria | Lung disease Associated with Hypercapnia | Asthma | Respiration Disorders
Item
no pulmonary disease (e.g., asthma or other respiratory disease) associated with hypercapnia
boolean
C0680251 (UMLS CUI [1])
C0024115 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0020440 (UMLS CUI [2,3])
C0004096 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
Exclusion Criteria | Metabolic Diseases Uncontrolled | Gastroparesis due to diabetes mellitus | Congestive heart failure Uncontrolled | Gastrointestinal Diseases Uncontrolled | Gastroesophageal reflux disease
Item
no uncontrolled metabolic disease (e.g., diabetes in the presence of gastroparesis, uncontrolled congestive heart failure, or uncontrolled gastrointestinal disorders [e.g., gerd])
boolean
C0680251 (UMLS CUI [1])
C0025517 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0267176 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0017178 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0017168 (UMLS CUI [6])
Exclusion Adverse reactions Dextromethorphan
Item
no prior adverse reaction to dextromethorphan
boolean
C2828389 (UMLS CUI [1,1])
C0559546 (UMLS CUI [1,2])
C0011816 (UMLS CUI [1,3])
Exclusion Criteria | Chronic liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic | Chronic alcoholic liver disease | Liver Cirrhosis chronic | Chronic fibrosis
Item
no history of chronic liver disease (e.g., hepatitis b or hepatitis c, alcoholic liver disease, cirrhosis, or fibrotic disease)
boolean
C0680251 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
C0524910 (UMLS CUI [4])
C4076349 (UMLS CUI [5])
C0023890 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C0334133 (UMLS CUI [7])
Fasting Overnight Able | Fasting Overnight Willing
Item
able and willing to fast overnight prior to the study session
boolean
C0015663 (UMLS CUI [1,1])
C0439583 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0015663 (UMLS CUI [2,1])
C0439583 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Follow-up Willing
Item
willing to return to mayo clinic for follow-up
boolean
C3274571 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Biospecimen Provide Willing
Item
willing to provide biologic specimens
boolean
C2347026 (UMLS CUI [1,1])
C1999230 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Pharmaceutical Preparations Previous Slowing Gastric Emptying | Pharmaceutical Preparations Previous Slowing Gastrointestinal Motility | Alcohol | Analgesics, Opioid | Anticholinergic Agents | Antihistamines | Loperamide
Item
more than 24 hours since prior medications known to slow gastric emptying or gastrointestinal motility (e.g., alcohol, opioid analgesics, anticholinergics [e.g., antihistamines], and loperamide)
boolean
C0013227 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0439834 (UMLS CUI [1,3])
C0017127 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0439834 (UMLS CUI [2,3])
C0017184 (UMLS CUI [2,4])
C0001975 (UMLS CUI [3])
C0002772 (UMLS CUI [4])
C0242896 (UMLS CUI [5])
C0003360 (UMLS CUI [6])
C0023992 (UMLS CUI [7])
C0162373 (UMLS CUI [8])
CYP2D6 Inhibitors Previous | Selective Serotonin Reuptake Inhibitors Previous | Paroxetine | Paxil | Fluoxetine | Prozac
Item
more than 4 weeks since prior and no concurrent cyp2d6 inhibitors or concurrent serotonin-reuptake inhibitors known to be potent cyp2d6 inhibitors (e.g.,paroxetine [paxil®] and fluoxetine [prozac®]
boolean
C3850058 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0360105 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0070122 (UMLS CUI [3])
C0376414 (UMLS CUI [4])
C0016365 (UMLS CUI [5])
C0162373 (UMLS CUI [6])
CYP2D6 Inhibitors Mild Patient need for | CYP2D6 Inhibitors Moderate Patient need for
Item
if mild to moderate inhibitors of cyp2d6 are medically necessary, patients may go back on after the 8-week time point
boolean
C3850058 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C3850058 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Monoamine Oxidase Inhibitors Previous | Furazolidone | Phenelzine | Procarbazine | Selegiline | Tranylcypromine
Item
more than 4 weeks since prior and no concurrent monoamine-oxidase inhibitors (e.g., furazolidone, phenelzine, procarbazine, selegiline, and tranylcypromine)
boolean
C0026457 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0016855 (UMLS CUI [2])
C0031392 (UMLS CUI [3])
C0033223 (UMLS CUI [4])
C0036579 (UMLS CUI [5])
C0040778 (UMLS CUI [6])
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