ID

38165

Description

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

Keywords

Versions (1)
  1. 9/23/19 9/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01980823

English

Eligibility Breast Cancer NCT01980823

1 forms  
Inclusion Criteria
Description

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
Description

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

Data type

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
Description

Tissue specimen pre treatment Analysis | Tissue specimen post treatment Analysis

Data type

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.
Description

Age

Data type

boolean

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

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

Data type

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
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Antidiabetics | Hypocholesteremic Agents

Data type

boolean

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

Investigational New Drugs

Data type

boolean

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

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

Data type

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
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

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
Description

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

Data type

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
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Similar models

Eligibility Breast Cancer NCT01980823

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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