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Fout:
ID
41165
Beschrijving
Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01566799
Link
https://clinicaltrials.gov/show/NCT01566799
Trefwoorden
Versies (1)
- 03-07-20 03-07-20 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
3 juli 2020
DOI
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Licentie
Creative Commons BY-NC 4.0
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Eligibility Locally Advanced Malignant Neoplasm NCT01566799
Eligibility Locally Advanced Malignant Neoplasm NCT01566799
- StudyEvent: Eligibility
Similar models
Eligibility Locally Advanced Malignant Neoplasm NCT01566799
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Gender | Age
Item
women older than 18 years old and younger than 70 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
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])
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])
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])
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])
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])
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])
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])
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])