ID

36851

Beschrijving

CAPSAICIN Trial: Assessing Capsaicin as a Chemopreventive Agent for Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02037464

Link

https://clinicaltrials.gov/show/NCT02037464

Trefwoorden

Versies (1)
  1. 16-06-19 16-06-19 -
Houder van rechten

See clinicaltrials.gov

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16 juni 2019

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02037464

Engels

Eligibility Prostate Cancer NCT02037464

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject is >19 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. subject has a histologically documented diagnosis of prostate adenocarcinoma
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
3. being monitored by active surveillance (see table 1) for favourable risk prostate cancer as defined by the following:
Beschrijving

Monitoring Surveillance Risk Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030695
UMLS CUI [1,2]
C0220920
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0600139
1. clinical stage t1b, t1c, t2a or t2b at the time of diagnosis
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
2. clinical (diagnostic biopsy) gleason score < 6
Beschrijving

Gleason score

Datatype

boolean

Alias
UMLS CUI [1]
C3203027
3. psa < 10.0 ng/ml (ug/l)
Beschrijving

Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
4. tumour material from most recent prostate biopsy available with sample (up to 10 unstained slides) collected for determination of ki67 and p27 biomarker expression.
Beschrijving

Tumor tissue sample Biopsy of prostate | Tumor tissue sample Unstained slide Quantity | Determination Ki-67 Expression | Determination p27 Expression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0194804
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C1883469
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0521095
UMLS CUI [3,2]
C0208804
UMLS CUI [3,3]
C0017262
UMLS CUI [4,1]
C0521095
UMLS CUI [4,2]
C0971007
UMLS CUI [4,3]
C0017262
5. scheduled to have an active surveillance mandated transrectal ultrasound (trus) guided biopsy within 6 - 12 months of day 1 of the study
Beschrijving

Transrectal ultrasound Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0373345
UMLS CUI [1,2]
C0205539
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous malignancy (not including curatively treated basal or squamous cell carcinoma of the skin) within the previous 5 years. (ta bladder cancer with negative surveillance cystoscopy within the past 2 years may be included.)
Beschrijving

Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0553723
2. no previous or current treatment (medical therapy or radical intervention) for prostate cancer excluding biopsy
Beschrijving

Therapeutic procedure Prostate carcinoma | Intervention Prostate carcinoma | Exception Biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0005558
3. inability to undergo trus biopsy
Beschrijving

Transrectal ultrasound Receive Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0373345
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
4. concurrent administration of the following medications is not permitted during the protocol:
Beschrijving

Pharmaceutical Preparations Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
5 α-reductase inhibitors
Beschrijving

5-alpha Reductase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C2936788
cytotoxic chemotherapy
Beschrijving

Cytotoxic Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0677881
immunotherapy
Beschrijving

Immunotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0021083
hormonal therapy (megestrol, medroxyprogesterone, cyproterone, diethylstilbestrol, hyrodcortisone, etc.)
Beschrijving

Hormone Therapy | Megestrol | Medroxyprogesterone | Cyproterone | Diethylstilbestrol | Hydrocortisone

Datatype

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0025175
UMLS CUI [3]
C0025147
UMLS CUI [4]
C0010621
UMLS CUI [5]
C0012203
UMLS CUI [6]
C0020268
non-steroidal anti-androgens (bicalutamide, nilutamide, flutamide, etc.)
Beschrijving

Nonsteroidal Anti-Androgens | bicalutamide | nilutamide | Flutamide

Datatype

boolean

Alias
UMLS CUI [1]
C1320169
UMLS CUI [2]
C0285590
UMLS CUI [3]
C0068771
UMLS CUI [4]
C0016384
luteinizing hormone releasing hormone (lhrh) analogues (leuprolide, goserelin, etc.)
Beschrijving

LHRH Analogue | Leuprolide | Goserelin

Datatype

boolean

Alias
UMLS CUI [1]
C1518041
UMLS CUI [2]
C0085272
UMLS CUI [3]
C0120107
ketoconazole
Beschrijving

Ketoconazole

Datatype

boolean

Alias
UMLS CUI [1]
C0022625
pc-spes and any other preparations thought to have endocrine effects
Beschrijving

PC-SPES | Pharmaceutical Preparations Endocrine effects

Datatype

boolean

Alias
UMLS CUI [1]
C0756934
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0678896
medications which inhibit cholesterogenesis ('statin' medications, etc.)
Beschrijving

Anticholesteremic Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003277
5. eastern cooperative oncology group (ecog) performance status > 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
6. known or history of liver disease (total bilirubin, alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 2.5 upper limit of normal at screening visit)
Beschrijving

Liver disease | Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
7. subject has a minimum life expectancy of < 5 years
Beschrijving

Life Expectancy Minimum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C1524031
8. subject is unable to give written and informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Prostate Cancer NCT02037464

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subject is >19 years of age
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
2. subject has a histologically documented diagnosis of prostate adenocarcinoma
boolean
C0007112 (UMLS CUI [1])
Monitoring Surveillance Risk Prostate carcinoma
Item
3. being monitored by active surveillance (see table 1) for favourable risk prostate cancer as defined by the following:
boolean
C0030695 (UMLS CUI [1,1])
C0220920 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0600139 (UMLS CUI [1,4])
TNM clinical staging
Item
1. clinical stage t1b, t1c, t2a or t2b at the time of diagnosis
boolean
C3258246 (UMLS CUI [1])
Gleason score
Item
2. clinical (diagnostic biopsy) gleason score < 6
boolean
C3203027 (UMLS CUI [1])
Prostate specific antigen measurement
Item
3. psa < 10.0 ng/ml (ug/l)
boolean
C0201544 (UMLS CUI [1])
Tumor tissue sample Biopsy of prostate | Tumor tissue sample Unstained slide Quantity | Determination Ki-67 Expression | Determination p27 Expression
Item
4. tumour material from most recent prostate biopsy available with sample (up to 10 unstained slides) collected for determination of ki67 and p27 biomarker expression.
boolean
C0475358 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
C0475358 (UMLS CUI [2,1])
C1883469 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0521095 (UMLS CUI [3,1])
C0208804 (UMLS CUI [3,2])
C0017262 (UMLS CUI [3,3])
C0521095 (UMLS CUI [4,1])
C0971007 (UMLS CUI [4,2])
C0017262 (UMLS CUI [4,3])
Transrectal ultrasound Scheduled
Item
5. scheduled to have an active surveillance mandated transrectal ultrasound (trus) guided biopsy within 6 - 12 months of day 1 of the study
boolean
C0373345 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin
Item
1. previous malignancy (not including curatively treated basal or squamous cell carcinoma of the skin) within the previous 5 years. (ta bladder cancer with negative surveillance cystoscopy within the past 2 years may be included.)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
Therapeutic procedure Prostate carcinoma | Intervention Prostate carcinoma | Exception Biopsy
Item
2. no previous or current treatment (medical therapy or radical intervention) for prostate cancer excluding biopsy
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
Transrectal ultrasound Receive Unable
Item
3. inability to undergo trus biopsy
boolean
C0373345 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Pharmaceutical Preparations Excluded
Item
4. concurrent administration of the following medications is not permitted during the protocol:
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
5-alpha Reductase Inhibitors
Item
5 α-reductase inhibitors
boolean
C2936788 (UMLS CUI [1])
Cytotoxic Chemotherapy
Item
cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1])
Immunotherapy
Item
immunotherapy
boolean
C0021083 (UMLS CUI [1])
Hormone Therapy | Megestrol | Medroxyprogesterone | Cyproterone | Diethylstilbestrol | Hydrocortisone
Item
hormonal therapy (megestrol, medroxyprogesterone, cyproterone, diethylstilbestrol, hyrodcortisone, etc.)
boolean
C0279025 (UMLS CUI [1])
C0025175 (UMLS CUI [2])
C0025147 (UMLS CUI [3])
C0010621 (UMLS CUI [4])
C0012203 (UMLS CUI [5])
C0020268 (UMLS CUI [6])
Nonsteroidal Anti-Androgens | bicalutamide | nilutamide | Flutamide
Item
non-steroidal anti-androgens (bicalutamide, nilutamide, flutamide, etc.)
boolean
C1320169 (UMLS CUI [1])
C0285590 (UMLS CUI [2])
C0068771 (UMLS CUI [3])
C0016384 (UMLS CUI [4])
LHRH Analogue | Leuprolide | Goserelin
Item
luteinizing hormone releasing hormone (lhrh) analogues (leuprolide, goserelin, etc.)
boolean
C1518041 (UMLS CUI [1])
C0085272 (UMLS CUI [2])
C0120107 (UMLS CUI [3])
Ketoconazole
Item
ketoconazole
boolean
C0022625 (UMLS CUI [1])
PC-SPES | Pharmaceutical Preparations Endocrine effects
Item
pc-spes and any other preparations thought to have endocrine effects
boolean
C0756934 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0678896 (UMLS CUI [2,2])
Anticholesteremic Agents
Item
medications which inhibit cholesterogenesis ('statin' medications, etc.)
boolean
C0003277 (UMLS CUI [1])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status > 2
boolean
C1520224 (UMLS CUI [1])
Liver disease | Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
6. known or history of liver disease (total bilirubin, alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 2.5 upper limit of normal at screening visit)
boolean
C0023895 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Life Expectancy Minimum
Item
7. subject has a minimum life expectancy of < 5 years
boolean
C0023671 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Informed Consent Unable
Item
8. subject is unable to give written and informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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