ID

37929

Beskrivning

Effect of Metformin on Breast Cancer Metabolism; ODM derived from: https://clinicaltrials.gov/show/NCT01266486

Länk

https://clinicaltrials.gov/show/NCT01266486

Nyckelord

Versioner (1)
  1. 2019-08-31 2019-08-31 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

31 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01266486

Engelsk

Eligibility Breast Cancer NCT01266486

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with histology proven locally advanced breast cancer (labc) or tumours >3 cm in diameter.
Beskrivning

Locally advanced breast cancer | Tumor Diameter

Datatyp

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1301886
ecog performance status 0-1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
age ≥18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
no prior treatment for breast cancer and scheduled to commence neoadjuvant chemotherapy in <3 weeks time.
Beskrivning

Prior Therapy Absent Breast Carcinoma | Neoadjuvant Chemotherapy Scheduled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [2,3]
C0205539
have given written informed consent and are capable of cooperating with protocol.
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
adequate bone marrow, renal and liver function.
Beskrivning

Bone Marrow function | Renal function | Liver function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiotherapy, major surgery, significant traumatic injury, endocrine therapy, immunotherapy, chemotherapy or experimental therapy during four weeks prior to starting or during trial.
Beskrivning

Therapeutic radiology procedure | Major surgery | Traumatic injury | Hormone Therapy | Immunotherapy | Chemotherapy | Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0679637
UMLS CUI [3]
C3263723
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0392920
UMLS CUI [7]
C0949266
pregnancy or breast feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of type 1 or type 2 diabetes.
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
serum glucose greater than 7.0 mmol/l.
Beskrivning

Glucose measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0202041
treatment with metformin in the past year.
Beskrivning

Metformin

Datatyp

boolean

Alias
UMLS CUI [1]
C0025598
estimated glomerular filtration rate (egfr) <45ml/min.
Beskrivning

Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C3811844
acute or chronic metabolic acidosis
Beskrivning

Metabolic acidosis | Chronic metabolic acidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0220981
UMLS CUI [2]
C0740749
known hypersensitivity to metformin
Beskrivning

Metformin allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0571648
other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
Beskrivning

Mental condition Study Subject Participation Status Poor | Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Interpretation Research results | Social Condition Study Subject Participation Status Poor | Social Condition Interferes with Protocol Compliance | Social Condition Interferes with Interpretation Research results | Medical condition Study Subject Participation Status Poor | Medical condition Interferes with Protocol Compliance | Medical condition Interferes with Interpretation Research results | Physical Examination Study Subject Participation Status Poor | Physical Examination Interferes with Protocol Compliance | Physical Examination Interferes with Interpretation Research results | Laboratory test result abnormal Study Subject Participation Status Poor | Laboratory test result abnormal Interferes with Protocol Compliance | Laboratory test result abnormal Interferes with Interpretation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2700379
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C0037403
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C2700379
UMLS CUI [5,1]
C0037403
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0037403
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C2700379
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0525058
UMLS CUI [9,1]
C3843040
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0459471
UMLS CUI [9,4]
C0683954
UMLS CUI [10,1]
C0031809
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C2700379
UMLS CUI [11,1]
C0031809
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0525058
UMLS CUI [12,1]
C0031809
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0459471
UMLS CUI [12,4]
C0683954
UMLS CUI [13,1]
C0438215
UMLS CUI [13,2]
C2348568
UMLS CUI [13,3]
C2700379
UMLS CUI [14,1]
C0438215
UMLS CUI [14,2]
C0521102
UMLS CUI [14,3]
C0525058
UMLS CUI [15,1]
C0438215
UMLS CUI [15,2]
C0521102
UMLS CUI [15,3]
C0459471
UMLS CUI [15,4]
C0683954
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Similar models

Eligibility Breast Cancer NCT01266486

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer | Tumor Diameter
Item
women with histology proven locally advanced breast cancer (labc) or tumours >3 cm in diameter.
boolean
C3495949 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status 0-1.
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
Prior Therapy Absent Breast Carcinoma | Neoadjuvant Chemotherapy Scheduled
Item
no prior treatment for breast cancer and scheduled to commence neoadjuvant chemotherapy in <3 weeks time.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
have given written informed consent and are capable of cooperating with protocol.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, renal and liver function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Major surgery | Traumatic injury | Hormone Therapy | Immunotherapy | Chemotherapy | Therapy, Investigational
Item
radiotherapy, major surgery, significant traumatic injury, endocrine therapy, immunotherapy, chemotherapy or experimental therapy during four weeks prior to starting or during trial.
boolean
C1522449 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0392920 (UMLS CUI [6])
C0949266 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
history of type 1 or type 2 diabetes.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Glucose measurement, serum
Item
serum glucose greater than 7.0 mmol/l.
boolean
C0202041 (UMLS CUI [1])
Metformin
Item
treatment with metformin in the past year.
boolean
C0025598 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate (egfr) <45ml/min.
boolean
C3811844 (UMLS CUI [1])
Metabolic acidosis | Chronic metabolic acidosis
Item
acute or chronic metabolic acidosis
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
Metformin allergy
Item
known hypersensitivity to metformin
boolean
C0571648 (UMLS CUI [1])
Mental condition Study Subject Participation Status Poor | Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Interpretation Research results | Social Condition Study Subject Participation Status Poor | Social Condition Interferes with Protocol Compliance | Social Condition Interferes with Interpretation Research results | Medical condition Study Subject Participation Status Poor | Medical condition Interferes with Protocol Compliance | Medical condition Interferes with Interpretation Research results | Physical Examination Study Subject Participation Status Poor | Physical Examination Interferes with Protocol Compliance | Physical Examination Interferes with Interpretation Research results | Laboratory test result abnormal Study Subject Participation Status Poor | Laboratory test result abnormal Interferes with Protocol Compliance | Laboratory test result abnormal Interferes with Interpretation Research results
Item
other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
boolean
C3840291 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2700379 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C0037403 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C2700379 (UMLS CUI [4,3])
C0037403 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0037403 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C3843040 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C2700379 (UMLS CUI [7,3])
C3843040 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
C3843040 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0459471 (UMLS CUI [9,3])
C0683954 (UMLS CUI [9,4])
C0031809 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C2700379 (UMLS CUI [10,3])
C0031809 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0525058 (UMLS CUI [11,3])
C0031809 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
C0438215 (UMLS CUI [13,1])
C2348568 (UMLS CUI [13,2])
C2700379 (UMLS CUI [13,3])
C0438215 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C0525058 (UMLS CUI [14,3])
C0438215 (UMLS CUI [15,1])
C0521102 (UMLS CUI [15,2])
C0459471 (UMLS CUI [15,3])
C0683954 (UMLS CUI [15,4])
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