ID

38165

Beschrijving

Pre-Surgical Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01980823

Link

https://clinicaltrials.gov/show/NCT01980823

Trefwoorden

Versies (1)
  1. 23-09-19 23-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 september 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT01980823

Engels

Eligibility Breast Cancer NCT01980823

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female subjects with histologically-confirmed operable invasive breast cancer or dcis, who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
Beschrijving

Gender | Invasive carcinoma of breast Operable | DCIS Operable | Core needle biopsy Followed by Excision

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0205188
UMLS CUI [3,1]
C0007124
UMLS CUI [3,2]
C0205188
UMLS CUI [4,1]
C1318309
UMLS CUI [4,2]
C0332283
UMLS CUI [4,3]
C0728940
> 5 mm by imaging/pathology of core to ensure enough pre- and post-treatment tissue for analysis
Beschrijving

Tissue specimen pre treatment Analysis | Tissue specimen post treatment Analysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C2709094
UMLS CUI [1,3]
C0002778
UMLS CUI [2,1]
C1292533
UMLS CUI [2,2]
C2709088
UMLS CUI [2,3]
C0002778
age ≥ 21 years. breast cancer is uncommon in patients less than this age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
no prior chemotherapy, radiation therapy, or breast resection within 6 months of study entry
Beschrijving

Prior Chemotherapy Absent | Prior radiation therapy Absent | Breast excision Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0191848
UMLS CUI [3,2]
C0332197
eastern cooperative oncology group (ecog) performance status 0-1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently on medication for diabetes or hypercholesterolemia
Beschrijving

Antidiabetics | Hypocholesteremic Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0020602
treatment with other investigational drugs within 6 months of study entry
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
strong cyp 3a4 inhibitors (e.g., clarithromycin, hiv protease inhibitors, and itraconazole), given potential interactions with atorvastatin
Beschrijving

CYP3A4 Inhibitors Strong | Clarithromycin | HIV Protease Inhibitors | Itraconazole | Interactions Atorvastatin

Datatype

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
UMLS CUI [2]
C0055856
UMLS CUI [3]
C0162714
UMLS CUI [4]
C0064113
UMLS CUI [5,1]
C0687133
UMLS CUI [5,2]
C0286651
renal impairment with a creatinine > 1.4 mg/dl
Beschrijving

Renal Insufficiency | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
hepatic impairment: aspartate transaminase (ast)/(sgot), alanine transaminase(alt)/(sgpt) > 2.5 x upper limit of normal range (uln), or total bilirubin > 1.5 x uln (subjects with gilbert's syndrome can have bilirubin of up to 1.5 x uln), or alkaline phosphatase > 2.5 x uln
Beschrijving

Hepatic impairment | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin | Gilbert Disease | Alkaline phosphatase raised

Datatype

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0741494
UMLS CUI [5]
C0017551
UMLS CUI [6]
C0151849
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT01980823

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Invasive carcinoma of breast Operable | DCIS Operable | Core needle biopsy Followed by Excision
Item
female subjects with histologically-confirmed operable invasive breast cancer or dcis, who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0205188 (UMLS CUI [2,2])
C0007124 (UMLS CUI [3,1])
C0205188 (UMLS CUI [3,2])
C1318309 (UMLS CUI [4,1])
C0332283 (UMLS CUI [4,2])
C0728940 (UMLS CUI [4,3])
Tissue specimen pre treatment Analysis | Tissue specimen post treatment Analysis
Item
> 5 mm by imaging/pathology of core to ensure enough pre- and post-treatment tissue for analysis
boolean
C1292533 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C0002778 (UMLS CUI [1,3])
C1292533 (UMLS CUI [2,1])
C2709088 (UMLS CUI [2,2])
C0002778 (UMLS CUI [2,3])
Age
Item
age ≥ 21 years. breast cancer is uncommon in patients less than this age.
boolean
C0001779 (UMLS CUI [1])
Prior Chemotherapy Absent | Prior radiation therapy Absent | Breast excision Absent
Item
no prior chemotherapy, radiation therapy, or breast resection within 6 months of study entry
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0191848 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics | Hypocholesteremic Agents
Item
currently on medication for diabetes or hypercholesterolemia
boolean
C0935929 (UMLS CUI [1])
C0020602 (UMLS CUI [2])
Investigational New Drugs
Item
treatment with other investigational drugs within 6 months of study entry
boolean
C0013230 (UMLS CUI [1])
CYP3A4 Inhibitors Strong | Clarithromycin | HIV Protease Inhibitors | Itraconazole | Interactions Atorvastatin
Item
strong cyp 3a4 inhibitors (e.g., clarithromycin, hiv protease inhibitors, and itraconazole), given potential interactions with atorvastatin
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C0055856 (UMLS CUI [2])
C0162714 (UMLS CUI [3])
C0064113 (UMLS CUI [4])
C0687133 (UMLS CUI [5,1])
C0286651 (UMLS CUI [5,2])
Renal Insufficiency | Creatinine measurement, serum
Item
renal impairment with a creatinine > 1.4 mg/dl
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Hepatic impairment | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin | Gilbert Disease | Alkaline phosphatase raised
Item
hepatic impairment: aspartate transaminase (ast)/(sgot), alanine transaminase(alt)/(sgpt) > 2.5 x upper limit of normal range (uln), or total bilirubin > 1.5 x uln (subjects with gilbert's syndrome can have bilirubin of up to 1.5 x uln), or alkaline phosphatase > 2.5 x uln
boolean
C0948807 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
C0017551 (UMLS CUI [5])
C0151849 (UMLS CUI [6])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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