ID

19046

Description

Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.; ODM derived from: https://clinicaltrials.gov/show/NCT00584532

Link

https://clinicaltrials.gov/show/NCT00584532

Keywords

  1. 12/1/16 12/1/16 -
Uploaded on

December 1, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00584532

Eligibility Prostate Cancer NCT00584532

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must be male and have a pathological diagnosis of prostate cancer
Description

Gender | Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0600139
pathological diagnosis of prostate cancer must be confirmed and on file with cra prior to study entry.
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
no treatment (surgery, radiation, or hormones) prior to study entry.
Description

Operative Surgical Procedures | Therapeutic radiology procedure | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279025
psa between 2.0 and 10.0 ng/ml.
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
if psa is >10.0, patient must have been on active surveillance for 12 months prior to study initiation.
Description

Raised prostate specific antigen | Patient Surveillance Duration

Data type

boolean

Alias
UMLS CUI [1]
C0178415
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0733511
UMLS CUI [2,3]
C0449238
no known allergy to soy or soy products.
Description

Allergy to soy | Hypersensitivity Soy product

Data type

boolean

Alias
UMLS CUI [1]
C4075590
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1532456
the patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (otc supplements).
Description

Genistein Unit per Gram per Day Dietary Supplements

Data type

boolean

Alias
UMLS CUI [1,1]
C0061202
UMLS CUI [1,2]
C2349072
UMLS CUI [1,3]
C0242295
participant has not been on any previous gcp clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
normal chemistry values prior to study entry.
Description

Chemistry normal

Data type

boolean

Alias
UMLS CUI [1]
C0854049
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no pathological documentation of prostate cancer.
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
prior treatment for prostate cancer.
Description

Therapeutic procedure Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600139
psa >10.0 ng/ml but not on active surveillance for 12 months.
Description

Raised prostate specific antigen | Patient Surveillance Duration

Data type

boolean

Alias
UMLS CUI [1]
C0178415
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0733511
UMLS CUI [2,3]
C0449238
allergy to soy or soy products.
Description

Allergy to soy | Hypersensitivity Soy product

Data type

boolean

Alias
UMLS CUI [1]
C4075590
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1532456
abnormal chemistry values.
Description

Chemistry abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0740327

Similar models

Eligibility Prostate Cancer NCT00584532

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Prostate carcinoma
Item
participants must be male and have a pathological diagnosis of prostate cancer
boolean
C0079399 (UMLS CUI [1])
C0600139 (UMLS CUI [2])
Prostate carcinoma
Item
pathological diagnosis of prostate cancer must be confirmed and on file with cra prior to study entry.
boolean
C0600139 (UMLS CUI [1])
Operative Surgical Procedures | Therapeutic radiology procedure | Hormone Therapy
Item
no treatment (surgery, radiation, or hormones) prior to study entry.
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
Prostate specific antigen measurement
Item
psa between 2.0 and 10.0 ng/ml.
boolean
C0201544 (UMLS CUI [1])
Raised prostate specific antigen | Patient Surveillance Duration
Item
if psa is >10.0, patient must have been on active surveillance for 12 months prior to study initiation.
boolean
C0178415 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0733511 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Allergy to soy | Hypersensitivity Soy product
Item
no known allergy to soy or soy products.
boolean
C4075590 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1532456 (UMLS CUI [2,2])
Genistein Unit per Gram per Day Dietary Supplements
Item
the patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (otc supplements).
boolean
C0061202 (UMLS CUI [1,1])
C2349072 (UMLS CUI [1,2])
C0242295 (UMLS CUI [1,3])
Study Subject Participation Status
Item
participant has not been on any previous gcp clinical trial.
boolean
C2348568 (UMLS CUI [1])
Chemistry normal
Item
normal chemistry values prior to study entry.
boolean
C0854049 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prostate carcinoma
Item
no pathological documentation of prostate cancer.
boolean
C0600139 (UMLS CUI [1])
Therapeutic procedure Prostate carcinoma
Item
prior treatment for prostate cancer.
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Raised prostate specific antigen | Patient Surveillance Duration
Item
psa >10.0 ng/ml but not on active surveillance for 12 months.
boolean
C0178415 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0733511 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Allergy to soy | Hypersensitivity Soy product
Item
allergy to soy or soy products.
boolean
C4075590 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1532456 (UMLS CUI [2,2])
Chemistry abnormal
Item
abnormal chemistry values.
boolean
C0740327 (UMLS CUI [1])

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