ID

44545

Beschreibung

A Study of Pre-operative Metformin in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00881725

Link

https://clinicaltrials.gov/show/NCT00881725

Stichworte

Versionen (2)
  1. 13.09.18 13.09.18 -
  2. 27.09.21 27.09.21 -
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See clinicaltrials.gov

Hochgeladen am

27. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00881725

Englisch

Eligibility Prostate Cancer NCT00881725

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 1. patients with histologically confirmed prostate cancer involving at least 20% of at least one unfragmented biopsy core;
Beschreibung

Prostate carcinoma | Involvement Percentage Core biopsy Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C1318309
UMLS CUI [2,4]
C1265611
2. over the age of 18 and under the age of 75;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. ability to read and understand the consent form, either alone or with the aid of a translator
Beschreibung

Able to read Consent Form | Comprehension Consent Form | Able to read Consent Form Translator Assisted | Comprehension Consent Form Translator Assisted

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0009797
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0009797
UMLS CUI [3,1]
C0586740
UMLS CUI [3,2]
C0009797
UMLS CUI [3,3]
C0040713
UMLS CUI [3,4]
C1269765
UMLS CUI [4,1]
C0162340
UMLS CUI [4,2]
C0009797
UMLS CUI [4,3]
C0040713
UMLS CUI [4,4]
C1269765
4. ecog performance status less than or equal to 2 (karnofsky greater than or equal to 60%);
Beschreibung

ECOG performance status | Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
5. patients must have their trus biopsy performed at uhn (or at an outside institution if tissue accession can be arranged) in the last 3 months;
Beschreibung

TRUS - Transrectal Ultrasonography

Datentyp

boolean

Alias
UMLS CUI [1]
C2960324
6. patients must have normal organ and marrow function as defined by the following criteria:
Beschreibung

Organ function | Bone Marrow function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
1. absolute neutrophil count greater than or equal to 1,500/ul
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
2. platelets greater than or equal to 100,000/ul
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
3. total bilirubin less than or equal to 1.5 x institutional uln
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
4. ast(sgot)/alt(sgpt) less than or equal to 1.5 x institutional uln
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
5. creatinine less than or equal to 1.4 x institutional uln
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who on initial assessment are found to be on treatment with any drug used for the treatment of any form of diabetes, or patients that begin treatment for any form of diabetes during the course of the study;
Beschreibung

Antidiabetics | Start Diabetes Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C0439659
UMLS CUI [2,2]
C3274787
2. patients may not be receiving any other investigational, herbal or anticancer agents while on study;
Beschreibung

Investigational New Drugs | Herbal medicine | Antineoplastic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2240391
UMLS CUI [3]
C0003392
3. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure (nyha class 3 or greater), cirrhosis with a child-pugh level of b or greater or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, clinically significant gastrointestinal conditions (e.g. crohns disease, ulcerative colitis), copd or psychiatric illness/social situations that would limit compliance with study requirements;
Beschreibung

Comorbidity Uncontrolled | Communicable Disease | Congestive heart failure New York Heart Association Classification | Liver Cirrhosis Child-Pugh Classification | Cardiac dysfunction | Angina, Unstable | Cardiac Arrhythmia | Peptic Ulcer | Gastrointestinal Diseases | Crohn Disease | Ulcerative Colitis | Chronic Obstructive Airway Disease | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C4050412
UMLS CUI [5]
C3277906
UMLS CUI [6]
C0002965
UMLS CUI [7]
C0003811
UMLS CUI [8]
C0030920
UMLS CUI [9]
C0017178
UMLS CUI [10]
C0010346
UMLS CUI [11]
C0009324
UMLS CUI [12]
C0024117
UMLS CUI [13,1]
C0004936
UMLS CUI [13,2]
C0439801
UMLS CUI [13,3]
C0525058
UMLS CUI [14,1]
C0748872
UMLS CUI [14,2]
C0439801
UMLS CUI [14,3]
C0525058
4. active malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin
Beschreibung

Cancer Other | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0553723
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
5. radiotherapy within the past 4 weeks;
Beschreibung

Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
6. patients with a current history of alcohol intake (>2 standard drinks/day) or binge drinking (5 or more drinks (male), or 4 or more drinks (female)) in one session of 1-3 hours;
Beschreibung

Alcohol consumption Drinks per day | Binge Drinking Drinks per day | Gender

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0439505
UMLS CUI [2,1]
C0556346
UMLS CUI [2,2]
C0001967
UMLS CUI [2,3]
C0439505
UMLS CUI [3]
C0079399
7. past history of lactic acidosis or risk factors for lactic acidosis such as congestive heart failure (nyha class 3 or greater), hypoxia (resting po2 < 91%) or renal insufficiency (egfr < 60 mls/min)
Beschreibung

Acidosis, Lactic | Risk factors Lactic Acidosis | Congestive heart failure New York Heart Association Classification | Hypoxia | PO2 measurement Resting | Renal Insufficiency | Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0001125
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0001125
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0242184
UMLS CUI [5,1]
C1283004
UMLS CUI [5,2]
C0035253
UMLS CUI [6]
C1565489
UMLS CUI [7]
C3811844
8. patients taking systemic glucocorticoids or estrogenic compounds.
Beschreibung

Glucocorticoids, Systemic | Estrogens

Datentyp

boolean

Alias
UMLS CUI [1]
C3540777
UMLS CUI [2]
C0014939
9. patients with known hypersensitivity or allergy to metformin or any of its excipients.
Beschreibung

Metformin allergy | Hypersensitivity Metformin Excipient

Datentyp

boolean

Alias
UMLS CUI [1]
C0571648
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0025598
UMLS CUI [2,3]
C0015237
10. patients with a history of impaired liver or kidney function.
Beschreibung

Liver Dysfunction | Renal Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00881725

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma | Involvement Percentage Core biopsy Quantity
Item
1. 1. patients with histologically confirmed prostate cancer involving at least 20% of at least one unfragmented biopsy core;
boolean
C0600139 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1318309 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Age
Item
2. over the age of 18 and under the age of 75;
boolean
C0001779 (UMLS CUI [1])
Able to read Consent Form | Comprehension Consent Form | Able to read Consent Form Translator Assisted | Comprehension Consent Form Translator Assisted
Item
3. ability to read and understand the consent form, either alone or with the aid of a translator
boolean
C0586740 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0009797 (UMLS CUI [2,2])
C0586740 (UMLS CUI [3,1])
C0009797 (UMLS CUI [3,2])
C0040713 (UMLS CUI [3,3])
C1269765 (UMLS CUI [3,4])
C0162340 (UMLS CUI [4,1])
C0009797 (UMLS CUI [4,2])
C0040713 (UMLS CUI [4,3])
C1269765 (UMLS CUI [4,4])
ECOG performance status | Karnofsky Performance Status
Item
4. ecog performance status less than or equal to 2 (karnofsky greater than or equal to 60%);
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
TRUS - Transrectal Ultrasonography
Item
5. patients must have their trus biopsy performed at uhn (or at an outside institution if tissue accession can be arranged) in the last 3 months;
boolean
C2960324 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
6. patients must have normal organ and marrow function as defined by the following criteria:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absolute neutrophil count
Item
1. absolute neutrophil count greater than or equal to 1,500/ul
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelets greater than or equal to 100,000/ul
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
3. total bilirubin less than or equal to 1.5 x institutional uln
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
4. ast(sgot)/alt(sgpt) less than or equal to 1.5 x institutional uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
5. creatinine less than or equal to 1.4 x institutional uln
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics | Start Diabetes Therapy
Item
1. patients who on initial assessment are found to be on treatment with any drug used for the treatment of any form of diabetes, or patients that begin treatment for any form of diabetes during the course of the study;
boolean
C0935929 (UMLS CUI [1])
C0439659 (UMLS CUI [2,1])
C3274787 (UMLS CUI [2,2])
Investigational New Drugs | Herbal medicine | Antineoplastic Agents
Item
2. patients may not be receiving any other investigational, herbal or anticancer agents while on study;
boolean
C0013230 (UMLS CUI [1])
C2240391 (UMLS CUI [2])
C0003392 (UMLS CUI [3])
Comorbidity Uncontrolled | Communicable Disease | Congestive heart failure New York Heart Association Classification | Liver Cirrhosis Child-Pugh Classification | Cardiac dysfunction | Angina, Unstable | Cardiac Arrhythmia | Peptic Ulcer | Gastrointestinal Diseases | Crohn Disease | Ulcerative Colitis | Chronic Obstructive Airway Disease | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
3. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure (nyha class 3 or greater), cirrhosis with a child-pugh level of b or greater or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, clinically significant gastrointestinal conditions (e.g. crohns disease, ulcerative colitis), copd or psychiatric illness/social situations that would limit compliance with study requirements;
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4,1])
C4050412 (UMLS CUI [4,2])
C3277906 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0030920 (UMLS CUI [8])
C0017178 (UMLS CUI [9])
C0010346 (UMLS CUI [10])
C0009324 (UMLS CUI [11])
C0024117 (UMLS CUI [12])
C0004936 (UMLS CUI [13,1])
C0439801 (UMLS CUI [13,2])
C0525058 (UMLS CUI [13,3])
C0748872 (UMLS CUI [14,1])
C0439801 (UMLS CUI [14,2])
C0525058 (UMLS CUI [14,3])
Cancer Other | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma
Item
4. active malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0553723 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Therapeutic radiology procedure
Item
5. radiotherapy within the past 4 weeks;
boolean
C1522449 (UMLS CUI [1])
Alcohol consumption Drinks per day | Binge Drinking Drinks per day | Gender
Item
6. patients with a current history of alcohol intake (>2 standard drinks/day) or binge drinking (5 or more drinks (male), or 4 or more drinks (female)) in one session of 1-3 hours;
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0556346 (UMLS CUI [2,1])
C0001967 (UMLS CUI [2,2])
C0439505 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3])
Acidosis, Lactic | Risk factors Lactic Acidosis | Congestive heart failure New York Heart Association Classification | Hypoxia | PO2 measurement Resting | Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
7. past history of lactic acidosis or risk factors for lactic acidosis such as congestive heart failure (nyha class 3 or greater), hypoxia (resting po2 < 91%) or renal insufficiency (egfr < 60 mls/min)
boolean
C0001125 (UMLS CUI [1])
C0035648 (UMLS CUI [2,1])
C0001125 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0242184 (UMLS CUI [4])
C1283004 (UMLS CUI [5,1])
C0035253 (UMLS CUI [5,2])
C1565489 (UMLS CUI [6])
C3811844 (UMLS CUI [7])
Glucocorticoids, Systemic | Estrogens
Item
8. patients taking systemic glucocorticoids or estrogenic compounds.
boolean
C3540777 (UMLS CUI [1])
C0014939 (UMLS CUI [2])
Metformin allergy | Hypersensitivity Metformin Excipient
Item
9. patients with known hypersensitivity or allergy to metformin or any of its excipients.
boolean
C0571648 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Liver Dysfunction | Renal Insufficiency
Item
10. patients with a history of impaired liver or kidney function.
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
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