ID

43523

Description

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

Lien

https://clinicaltrials.gov/show/NCT00873366

Mots-clés

Versions (2)
  1. 23/10/2017 23/10/2017 -
  2. 20/09/2021 20/09/2021 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

20 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Breast Cancer NCT00873366

Anglais

Eligibility Breast Cancer NCT00873366

1 Formulaires  
Criteria
Description

Criteria

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

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

Type de données

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
Description

CYP2D6 gene Known

Type de données

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
Description

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

Type de données

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
Description

Hormone Receptor Status Unspecified

Type de données

boolean

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

Client Characteristics

Type de données

boolean

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

Menopausal Status Unspecified

Type de données

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
ecog performance status 0-2
Description

ECOG performance status

Type de données

boolean

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

Life Expectancy

Type de données

boolean

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

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

Type de données

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
Description

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

Type de données

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])
Description

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

Type de données

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
Description

Exclusion Adverse reactions Dextromethorphan

Type de données

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)
Description

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

Type de données

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
Description

Fasting Overnight Able | Fasting Overnight Willing

Type de données

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
Description

Follow-up Willing

Type de données

boolean

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

Biospecimen Provide Willing

Type de données

boolean

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

Therapeutic procedure

Type de données

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)
Description

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

Type de données

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]
C0019590
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®]
Description

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

Type de données

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
Description

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

Type de données

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)
Description

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

Type de données

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
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT00873366

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
C3829127 (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])
C0019590 (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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial