ID

41164

Description

Study of Propranolol in Newly Diagnosed Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01847001

Lien

https://clinicaltrials.gov/show/NCT01847001

Mots-clés

Versions (1)
  1. 03/07/2020 03/07/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

3 juillet 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 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 Locally Advanced Breast Cancer NCT01847001

Anglais

Eligibility Locally Advanced Breast Cancer NCT01847001

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
english or spanish speaking women age ≥18
Description

Able to speak English Language | Able to speak Spanish Language | Gender | Age

Type de données

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0037750
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0001779
heart rate > 60 bpm
Description

Heart rate

Type de données

boolean

Alias
UMLS CUI [1]
C0018810
systolic blood pressure > 100 mm/hg
Description

Systolic Pressure

Type de données

boolean

Alias
UMLS CUI [1]
C0871470
deemed eligible to receive neoadjuvant chemotherapy with 12 cycles of weekly taxane therapy (paclitaxel 80mg/m2 or abraxane 100 mg/m2 if there is a shortage of paclitaxel) followed by 4 cycles of adriamycin (60mg/m2) and cyclophosphamide (600 mg/m2) given every 2 weeks with growth-factor support.
Description

Neoadjuvant Chemotherapy | Chemotherapy cycle Quantity | taxane | Paclitaxel Dose | Abraxane Dose | Adriamycin Dose | Cyclophosphamide Dose | Growth Factor Support

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0215136
UMLS CUI [4,1]
C0144576
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C1564985
UMLS CUI [5,2]
C0178602
UMLS CUI [6,1]
C0085752
UMLS CUI [6,2]
C0178602
UMLS CUI [7,1]
C0010583
UMLS CUI [7,2]
C0178602
UMLS CUI [8,1]
C0018284
UMLS CUI [8,2]
C1521721
echocardiogram (echo) or multiple-gated acquisition scan (muga) with ejection fraction > 50%.
Description

Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan

Type de données

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0521317
patients with hormone receptor +/- and human epidermal growth factor receptor 2 protein (her2) +/- breast cancer are eligible
Description

Hormone Receptor Positive Breast Carcinoma | Breast Carcinoma Hormone Receptor Negative | HER2-positive carcinoma of breast | HER2-negative breast cancer

Type de données

boolean

Alias
UMLS CUI [1]
C4745240
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0019929
UMLS CUI [2,3]
C1513916
UMLS CUI [3]
C1960398
UMLS CUI [4]
C4733095
if a patient has her2-positive breast cancer, herceptin and perjeta will be given along with taxane therapy
Description

HER2-positive carcinoma of breast | Herceptin | Perjeta | taxane

Type de données

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2]
C0338204
UMLS CUI [3]
C3473371
UMLS CUI [4]
C0215136
any stage invasive breast cancer provided the primary breast tumor size is ≥ 1 cm
Description

Invasive carcinoma of breast TNM Breast tumor staging | Breast Carcinoma Size

Type de données

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0456389
agree to participate in research blood collection at 4 different time periods (20 ml = 4 teaspoons)
Description

Collection of blood specimen

Type de données

boolean

Alias
UMLS CUI [1]
C0005834
agree to the evaluation of already collected core biopsy, as well as surgical resection tissue, for predictive biomarkers. the biopsy prior to taxol #1 is optional.
Description

Core biopsy Evaluation | Evaluation Tissue Excisional | Biomarkers

Type de données

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C1261322
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0040300
UMLS CUI [2,3]
C0728940
UMLS CUI [3]
C0005516
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients failing to meet the inclusion criteria
Description

Inclusion criteria Failed

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0231175
corrected qt interval (qtc) prolongation as defined by > 470 milliseconds on electrocardiogram (ecg)
Description

Prolonged QTc interval on electrocardiogram (ECG)

Type de données

boolean

Alias
UMLS CUI [1]
C4015677
first degree av block on ecg in which pr interval lengthened > 200 milliseconds; second degree; or third degree
Description

First degree atrioventricular block ECG | Second degree atrioventricular block ECG | Complete atrioventricular block ECG | Prolonged PR interval

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085614
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C0264906
UMLS CUI [2,2]
C0013798
UMLS CUI [3,1]
C0151517
UMLS CUI [3,2]
C0013798
UMLS CUI [4]
C0600125
on beta-blocker treatment. if discontinued, patients must have been off beta-blockers for at least 3 months.
Description

Adrenergic beta-1 Receptor Antagonists

Type de données

boolean

Alias
UMLS CUI [1]
C0304516
history of asthma, given concern for β-blockade in this population
Description

History of asthma

Type de données

boolean

Alias
UMLS CUI [1]
C0455544
Retour au début de la page

Similar models

Eligibility Locally Advanced Breast Cancer NCT01847001

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Able to speak English Language | Able to speak Spanish Language | Gender | Age
Item
english or spanish speaking women age ≥18
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Heart rate
Item
heart rate > 60 bpm
boolean
C0018810 (UMLS CUI [1])
Systolic Pressure
Item
systolic blood pressure > 100 mm/hg
boolean
C0871470 (UMLS CUI [1])
Neoadjuvant Chemotherapy | Chemotherapy cycle Quantity | taxane | Paclitaxel Dose | Abraxane Dose | Adriamycin Dose | Cyclophosphamide Dose | Growth Factor Support
Item
deemed eligible to receive neoadjuvant chemotherapy with 12 cycles of weekly taxane therapy (paclitaxel 80mg/m2 or abraxane 100 mg/m2 if there is a shortage of paclitaxel) followed by 4 cycles of adriamycin (60mg/m2) and cyclophosphamide (600 mg/m2) given every 2 weeks with growth-factor support.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0215136 (UMLS CUI [3])
C0144576 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C1564985 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0085752 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0010583 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0018284 (UMLS CUI [8,1])
C1521721 (UMLS CUI [8,2])
Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan
Item
echocardiogram (echo) or multiple-gated acquisition scan (muga) with ejection fraction > 50%.
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Hormone Receptor Positive Breast Carcinoma | Breast Carcinoma Hormone Receptor Negative | HER2-positive carcinoma of breast | HER2-negative breast cancer
Item
patients with hormone receptor +/- and human epidermal growth factor receptor 2 protein (her2) +/- breast cancer are eligible
boolean
C4745240 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0019929 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C1960398 (UMLS CUI [3])
C4733095 (UMLS CUI [4])
HER2-positive carcinoma of breast | Herceptin | Perjeta | taxane
Item
if a patient has her2-positive breast cancer, herceptin and perjeta will be given along with taxane therapy
boolean
C1960398 (UMLS CUI [1])
C0338204 (UMLS CUI [2])
C3473371 (UMLS CUI [3])
C0215136 (UMLS CUI [4])
Invasive carcinoma of breast TNM Breast tumor staging | Breast Carcinoma Size
Item
any stage invasive breast cancer provided the primary breast tumor size is ≥ 1 cm
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Collection of blood specimen
Item
agree to participate in research blood collection at 4 different time periods (20 ml = 4 teaspoons)
boolean
C0005834 (UMLS CUI [1])
Core biopsy Evaluation | Evaluation Tissue Excisional | Biomarkers
Item
agree to the evaluation of already collected core biopsy, as well as surgical resection tissue, for predictive biomarkers. the biopsy prior to taxol #1 is optional.
boolean
C1318309 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1261322 (UMLS CUI [2,1])
C0040300 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
C0005516 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Failed
Item
patients failing to meet the inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Prolonged QTc interval on electrocardiogram (ECG)
Item
corrected qt interval (qtc) prolongation as defined by > 470 milliseconds on electrocardiogram (ecg)
boolean
C4015677 (UMLS CUI [1])
First degree atrioventricular block ECG | Second degree atrioventricular block ECG | Complete atrioventricular block ECG | Prolonged PR interval
Item
first degree av block on ecg in which pr interval lengthened > 200 milliseconds; second degree; or third degree
boolean
C0085614 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0264906 (UMLS CUI [2,1])
C0013798 (UMLS CUI [2,2])
C0151517 (UMLS CUI [3,1])
C0013798 (UMLS CUI [3,2])
C0600125 (UMLS CUI [4])
Adrenergic beta-1 Receptor Antagonists
Item
on beta-blocker treatment. if discontinued, patients must have been off beta-blockers for at least 3 months.
boolean
C0304516 (UMLS CUI [1])
History of asthma
Item
history of asthma, given concern for β-blockade in this population
boolean
C0455544 (UMLS CUI [1])
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