Eligibility Prostate Cancer NCT02511665

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StudyEvent: Eligibility
1. Eligibility Prostate Cancer NCT02511665

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age | Informed Consent

Item

1. age 18 or older and willing and able to provide signed informed consent.

boolean

C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])

Adenocarcinoma of prostate | Tumor Length Core biopsy

Item

2. histologically confirmed adenocarcinoma of the prostate , with a minimum maximal tumour length of greater than 6mm on core biopsy

boolean

C0007112 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C1318309 (UMLS CUI [2,3])

Prior Therapy Absent Prostate carcinoma | Operative Surgical Procedures Absent | Hormone Therapy Absent | Therapeutic radiology procedure Absent | Cold Therapy Absent

Item

3. no previous treatment for prostate cancer (including surgery, any hormone therapy, radiotherapy and cryotherapy)

boolean

C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0010412 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])

Biopsy of prostate | Material Biological Marker Assessment

Item

4. prostate biopsy within 8 weeks from screening which contains sufficient material for baseline molecular marker assessment at guy's and st thomas' nhs foundation trust..

boolean

C0194804 (UMLS CUI [1])
C0520510 (UMLS CUI [2,1])
C0005516 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])

Radical prostatectomy Scheduled

Item

5. radical prostatectomy is the scheduled treatment of choice

boolean

C0194810 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])

ECOG performance status

Item

6. eastern cooperative oncology group (ecog) performance status less than or equal to 0 or 1.

boolean

C1520224 (UMLS CUI [1])

Organ function

Item

7. adequate organ function, defined as follows:

boolean

C0678852 (UMLS CUI [1])

Hemoglobin measurement

Item

haemoglobin >10.0g/dl

boolean

C0518015 (UMLS CUI [1])

Absolute neutrophil count

Item

absolute neutrophil count >1.5x109/l

boolean

C0948762 (UMLS CUI [1])

Platelet Count measurement

Item

platelet count >100x109/l

boolean

C0032181 (UMLS CUI [1])

Renal function | Estimated Glomerular Filtration Rate Cockcroft-Gault formula

Item

renal function, egfr >60ml/min (calculated by cockcroft gault)

boolean

C0232804 (UMLS CUI [1])
C3811844 (UMLS CUI [2,1])
C2924627 (UMLS CUI [2,2])

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Item

ast and/or alt <2.5 x uln

boolean

C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])

Serum total bilirubin measurement

Item

total bilirubin <1.5 x uln

boolean

C1278039 (UMLS CUI [1])

Able to swallow Oral medication | Protocol Compliance

Item

8. able to swallow the drug and comply with study requirements.

boolean

C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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

Item

1. patients with a current or historical diagnosis of type one or two diabetes and/or have ever received metformin

boolean

C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0025598 (UMLS CUI [3])

Hypersensitivity Metformin Component | Hypersensitivity Placebo Oral Tablet Component

Item

2. patients with hypersensitivity to any of the components of metformin or placebo tablet

boolean

C0020517 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1249327 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])

Condition Associated with Lactic Acidosis | Shock | Pulmonary Insufficiency | Alcoholic Intoxication, Chronic | Condition Associated with Hypoxemia

Item

3. history of or conditions associated with lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), and conditions associated with hypoxaemia

boolean

C0348080 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0001125 (UMLS CUI [1,3])
C0036974 (UMLS CUI [2])
C0034088 (UMLS CUI [3])
C0001973 (UMLS CUI [4])
C0348080 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0700292 (UMLS CUI [5,3])

Item

4. patients with chronic liver disease, severe cardiovascular impairment, cardiac failure, recent myocardial infarction, severe peripheral vascular disease or renal impairment (egfr <60ml/min as measured by cockcroft gault)

boolean

C0341439 (UMLS CUI [1])
C2080705 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085096 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1565489 (UMLS CUI [6])
C3811844 (UMLS CUI [7,1])
C2924627 (UMLS CUI [7,2])

Item

5. patients with acute severe disorders, for example infections with fever, pancreatitis, trauma, dehydration or reduced diet (<1000kcal or 4200kj per day)

boolean

C1836348 (UMLS CUI [1])
C0948233 (UMLS CUI [2])
C0030305 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
C0011175 (UMLS CUI [5])
C0012167 (UMLS CUI [6])

Cancer Other Requirement Systemic therapy

Item

6. other active malignancy over the last five years that has required systemic therapy, excluding:

boolean

C1707251 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])

Exception Adjuvant therapy Curative

Item

adjuvant therapy in the curative setting

boolean

C1705847 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])

Exception Skin carcinoma

Item

non-melanoma skin cancer

boolean

C1705847 (UMLS CUI [1,1])
C0699893 (UMLS CUI [1,2])

Exception Transitional Cell Carcinoma Superficial TNM clinical staging

Item

superficial transitional cell carcinoma (cis-t1)

boolean

C1705847 (UMLS CUI [1,1])
C0007138 (UMLS CUI [1,2])
C0205124 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Item

7. current enrolment in an investigational drug or device study or participation in such a study within 30 days of signing consent.

boolean

C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])

Male fertility Barrier Contraception Unwilling | Male fertility Condom use Unwilling

Item

8. any subjects who is able to father a child and does not agree to use barrier protection, in the form of a condom ,for the duration of the trial and for 16 weeks after the last study drug administration.

boolean

C1955321 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C1955321 (UMLS CUI [2,1])
C0679782 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])

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Eligibility Prostate Cancer NCT02511665