ID

41165

Description

Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01566799

Link

https://clinicaltrials.gov/show/NCT01566799

Keywords

  1. 7/3/20 7/3/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 3, 2020

DOI

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License

Creative Commons BY-NC 4.0

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Eligibility Locally Advanced Malignant Neoplasm NCT01566799

Eligibility Locally Advanced Malignant Neoplasm NCT01566799

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women older than 18 years old and younger than 70 years old
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
invasive breast cancer confirmed by core biopsy, any histology
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
tumor ≥2 cm and/or lymph node positive (proven by fna)(t2-4b, n0-3, m0)
Description

Tumor size | Positive Lymph Node Fine needle aspiration biopsy | TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2,1]
C0746319
UMLS CUI [2,2]
C1510483
UMLS CUI [3]
C0474926
must have er/pr positive and her2 negative
Description

Estrogen receptor positive | Progesterone receptor positive | HER2 Negative

Data type

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
UMLS CUI [3]
C2348908
must have full staging and extent disease and clinically and radiographically tumor measure
Description

Disease TNM Breast tumor staging | Tumor size

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0475440
without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy)
Description

Prior Therapy Absent Breast Carcinoma | Operative Surgical Procedure Absent | Hormone Therapy Absent | Chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0332197
normal liver, kidney and blood tests
Description

Liver function tests normal | Kidney Function Tests Normal | Blood test normal

Data type

boolean

Alias
UMLS CUI [1]
C0438235
UMLS CUI [2,1]
C0022662
UMLS CUI [2,2]
C0205307
UMLS CUI [3]
C0919709
performance status ecog 0-2 o karnofsky ≥70%
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
fasten glucose levels <125 mg/dl
Description

Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1]
C0202045
signed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous use of metformin for any indication
Description

metformin

Data type

boolean

Alias
UMLS CUI [1]
C0025598
presence of diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849

Similar models

Eligibility Locally Advanced Malignant Neoplasm NCT01566799

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women older than 18 years old and younger than 70 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast
Item
invasive breast cancer confirmed by core biopsy, any histology
boolean
C0853879 (UMLS CUI [1])
Tumor size | Positive Lymph Node Fine needle aspiration biopsy | TNM Breast tumor staging
Item
tumor ≥2 cm and/or lymph node positive (proven by fna)(t2-4b, n0-3, m0)
boolean
C0475440 (UMLS CUI [1])
C0746319 (UMLS CUI [2,1])
C1510483 (UMLS CUI [2,2])
C0474926 (UMLS CUI [3])
Estrogen receptor positive | Progesterone receptor positive | HER2 Negative
Item
must have er/pr positive and her2 negative
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
C2348908 (UMLS CUI [3])
Disease TNM Breast tumor staging | Tumor size
Item
must have full staging and extent disease and clinically and radiographically tumor measure
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2])
Prior Therapy Absent Breast Carcinoma | Operative Surgical Procedure Absent | Hormone Therapy Absent | Chemotherapy Absent
Item
without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy)
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Liver function tests normal | Kidney Function Tests Normal | Blood test normal
Item
normal liver, kidney and blood tests
boolean
C0438235 (UMLS CUI [1])
C0022662 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0919709 (UMLS CUI [3])
ECOG performance status | Karnofsky Performance Status
Item
performance status ecog 0-2 o karnofsky ≥70%
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Glucose measurement, fasting
Item
fasten glucose levels <125 mg/dl
boolean
C0202045 (UMLS CUI [1])
Informed Consent
Item
signed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
metformin
Item
previous use of metformin for any indication
boolean
C0025598 (UMLS CUI [1])
Diabetes Mellitus
Item
presence of diabetes mellitus
boolean
C0011849 (UMLS CUI [1])

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