ID

26193

Beskrivning

Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00167648

Länk

https://clinicaltrials.gov/show/NCT00167648

Nyckelord

Versioner (1)
  1. 2017-10-11 2017-10-11 -
Rättsinnehavare

see clinicaltrials.gov

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11 oktober 2017

DOI

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Creative Commons BY 4.0
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Eligibility Cancer NCT00167648

Engelsk

Eligibility Cancer NCT00167648

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00167648
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men 18 years or older with a histologic diagnosis of low to intermediate risk prostate cancer prior to radical prostatectomy as defined by:
Beskrivning

Age and histologic diagnosis to intermediate risk prostate cancer prior to radical prostatectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0033578
UMLS CUI [2,2]
C0344441
UMLS CUI [2,3]
C0035648
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0194810
1. clinical stage t1-t2b
Beskrivning

Clinical Stage

Datatyp

boolean

Alias
UMLS CUI [1]
C1300072
2. psa < 20
Beskrivning

PSA measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201544
3. gleason score < 7
Beskrivning

Gleason score

Datatyp

boolean

Alias
UMLS CUI [1]
C0332326
patients who have more than one of the following prognostic factors: t2b, gleason 7, psa 10-20 are not eligible.
Beskrivning

Prognostic Factors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514474
UMLS CUI [1,2]
C1300072
UMLS CUI [2,1]
C1514474
UMLS CUI [2,2]
C0332326
UMLS CUI [3,1]
C1514474
UMLS CUI [3,2]
C0138741
2. patient's tumor must be considered surgically resectable as determined by a urologic evaluation
Beskrivning

Surgically resectable as determined by a urologic evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0042077
3. ecog performance status of 0-1
Beskrivning

Ecog performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. life expectancy greater than 2 years
Beskrivning

Life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
5. able to understand and give informed consent
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
6. patients must agree not to take dietary phytoestrogens or other estrogen containing supplements
Beskrivning

Compliance behavior concomitant medications

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2347852
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with locally advanced or high-risk disease as defined above.
Beskrivning

Locally adcanced or high-risk disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0677984
UMLS CUI [2]
C0475283
2. patients who have a testosterone less than 280 ng/dl.
Beskrivning

Testosterone Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0523912
3. patients who have evidence of cerebrovascular accident or ischemia, recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
Beskrivning

Comorbidities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0038454
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0917798
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0332185
UMLS CUI [3,3]
C0149871
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0034065
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C0002965
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0018802
4. patients who are receiving any other investigational therapy.
Beskrivning

Investigational therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
5. patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
Beskrivning

Active serious Infection and Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
6. dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
Beskrivning

Limited ability to give informed consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
7. patients with immunodeficiency or on oral corticosteroids
Beskrivning

Immunodeficiency or oral corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0239126
8. histologic evidence of small cell carcinoma of the prostate.
Beskrivning

Histologic evidence of small cell carcinoma of the prostate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262584
UMLS CUI [1,2]
C0033572
UMLS CUI [1,3]
C0344441
9. patients with a prior history of myocardial infarction, pulmonary embolism, cva or atrial fibrillation.
Beskrivning

Patients with a prior history of myocardial infarction, pulmonary embolism, cva or atrial fibrillation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0027051
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0034065
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0038454
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0004238
10. patients with active thrombophlebitis.
Beskrivning

Patients with active thrombophlebitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0040046
11. patients with evidence of active angina as evidenced by chest pain responsive to nitroglycerin or other anginal equivalent.
Beskrivning

Vasidilator responsive angina pectoris

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0205342
UMLS CUI [1,3]
C0042402
12. medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained
Beskrivning

medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1113679
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0242568
13. patients who are currently receiving active therapy for other neoplastic disorders will not be eligible for study.
Beskrivning

Active therpy for other neoplastic disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085183
UMLS CUI [1,2]
C0597030
14. patients taking any of the following medications who cannot discontinue these medications for three weeks during administration of androgen deprivation: aprepitant, bexarotene, clarithromycin, itraconazole, ketoconazole, st. john's wort.
Beskrivning

Ongoing medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C1176306
UMLS CUI [2,1]
C2826666
UMLS CUI [2,2]
C0765273
UMLS CUI [3,1]
C2826666
UMLS CUI [3,2]
C0055856
UMLS CUI [4,1]
C2826666
UMLS CUI [4,2]
C0064113
UMLS CUI [5,1]
C2826666
UMLS CUI [5,2]
C0022625
UMLS CUI [6,1]
C2826666
UMLS CUI [6,2]
C0936242
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Similar models

Eligibility Cancer NCT00167648

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00167648
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age and histologic diagnosis to intermediate risk prostate cancer prior to radical prostatectomy
Item
1. men 18 years or older with a histologic diagnosis of low to intermediate risk prostate cancer prior to radical prostatectomy as defined by:
boolean
C0001779 (UMLS CUI [1])
C0033578 (UMLS CUI [2,1])
C0344441 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
C0332152 (UMLS CUI [3,1])
C0194810 (UMLS CUI [3,2])
Clinical Stage
Item
1. clinical stage t1-t2b
boolean
C1300072 (UMLS CUI [1])
PSA measurement
Item
2. psa < 20
boolean
C0201544 (UMLS CUI [1])
Gleason score
Item
3. gleason score < 7
boolean
C0332326 (UMLS CUI [1])
Prognostic Factors
Item
patients who have more than one of the following prognostic factors: t2b, gleason 7, psa 10-20 are not eligible.
boolean
C1514474 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C1514474 (UMLS CUI [2,1])
C0332326 (UMLS CUI [2,2])
C1514474 (UMLS CUI [3,1])
C0138741 (UMLS CUI [3,2])
Surgically resectable as determined by a urologic evaluation
Item
2. patient's tumor must be considered surgically resectable as determined by a urologic evaluation
boolean
C0543467 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0042077 (UMLS CUI [1,3])
Ecog performance status
Item
3. ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Life expectancy
Item
4. life expectancy greater than 2 years
boolean
C0023671 (UMLS CUI [1])
Informed consent
Item
5. able to understand and give informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior concomitant medications
Item
6. patients must agree not to take dietary phytoestrogens or other estrogen containing supplements
boolean
C1321605 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Locally adcanced or high-risk disease
Item
1. patients with locally advanced or high-risk disease as defined above.
boolean
C0677984 (UMLS CUI [1])
C0475283 (UMLS CUI [2])
Testosterone Measurement
Item
2. patients who have a testosterone less than 280 ng/dl.
boolean
C0523912 (UMLS CUI [1])
Comorbidities
Item
3. patients who have evidence of cerebrovascular accident or ischemia, recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
boolean
C0009488 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0917798 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0149871 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C0034065 (UMLS CUI [4,2])
C0009488 (UMLS CUI [5,1])
C0002965 (UMLS CUI [5,2])
C0009488 (UMLS CUI [6,1])
C0018802 (UMLS CUI [6,2])
Investigational therapy
Item
4. patients who are receiving any other investigational therapy.
boolean
C2348568 (UMLS CUI [1])
Active serious Infection and Comorbidity
Item
5. patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
boolean
C0009450 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Limited ability to give informed consent
Item
6. dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Immunodeficiency or oral corticosteroids
Item
7. patients with immunodeficiency or on oral corticosteroids
boolean
C0021051 (UMLS CUI [1])
C0239126 (UMLS CUI [2])
Histologic evidence of small cell carcinoma of the prostate
Item
8. histologic evidence of small cell carcinoma of the prostate.
boolean
C0262584 (UMLS CUI [1,1])
C0033572 (UMLS CUI [1,2])
C0344441 (UMLS CUI [1,3])
Patients with a prior history of myocardial infarction, pulmonary embolism, cva or atrial fibrillation
Item
9. patients with a prior history of myocardial infarction, pulmonary embolism, cva or atrial fibrillation.
boolean
C0262926 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0034065 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0038454 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C0004238 (UMLS CUI [4,2])
Patients with active thrombophlebitis
Item
10. patients with active thrombophlebitis.
boolean
C0040046 (UMLS CUI [1])
Vasidilator responsive angina pectoris
Item
11. patients with evidence of active angina as evidenced by chest pain responsive to nitroglycerin or other anginal equivalent.
boolean
C0002962 (UMLS CUI [1,1])
C0205342 (UMLS CUI [1,2])
C0042402 (UMLS CUI [1,3])
medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained
Item
12. medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained
boolean
C0009488 (UMLS CUI [1,1])
C1113679 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0242568 (UMLS CUI [2,2])
Active therpy for other neoplastic disorders
Item
13. patients who are currently receiving active therapy for other neoplastic disorders will not be eligible for study.
boolean
C0085183 (UMLS CUI [1,1])
C0597030 (UMLS CUI [1,2])
Ongoing medication
Item
14. patients taking any of the following medications who cannot discontinue these medications for three weeks during administration of androgen deprivation: aprepitant, bexarotene, clarithromycin, itraconazole, ketoconazole, st. john's wort.
boolean
C2826666 (UMLS CUI [1,1])
C1176306 (UMLS CUI [1,2])
C2826666 (UMLS CUI [2,1])
C0765273 (UMLS CUI [2,2])
C2826666 (UMLS CUI [3,1])
C0055856 (UMLS CUI [3,2])
C2826666 (UMLS CUI [4,1])
C0064113 (UMLS CUI [4,2])
C2826666 (UMLS CUI [5,1])
C0022625 (UMLS CUI [5,2])
C2826666 (UMLS CUI [6,1])
C0936242 (UMLS CUI [6,2])
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