ID

44561

Description

Effects of Tomato-Soy Juice on Biomarkers in Patients With Prostate Cancer Undergoing Prostatectomy; ODM derived from: https://clinicaltrials.gov/show/NCT01009736

Link

https://clinicaltrials.gov/show/NCT01009736

Keywords

Versions (2)
  1. 9/17/18 9/17/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01009736

English

Eligibility Prostate Cancer NCT01009736

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy proven carcinoma of the prostate.
Description

Biopsy of prostate showed carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C4030352
have chosen radical prostatectomy (or cystoprostatectomy) for treatment of their disease after presented all possible options by medical team.
Description

Radical prostatectomy Chosen | Radical cystoprostatectomy Chosen

Data type

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C1707391
UMLS CUI [2,1]
C0194412
UMLS CUI [2,2]
C1707391
not receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
Description

Hormone Therapy Neoadjuvant Absent | Chemotherapy Neoadjuvant Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C0332197
ecog (eastern cooperative oncology group) performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
not currently taking lycopene, soy dietary supplements, or "alternative" products (i.e. pc-spes, saw palmetto).
Description

Lycopene Absent | Soy Dietary Supplements Absent | Alternative medicine agent Absent | PC-SPES Absent | Saw palmetto extract Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0065331
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0037733
UMLS CUI [2,2]
C0242295
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1626216
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0756934
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0771607
UMLS CUI [5,2]
C0332197
bun/cr (blood urea nitrogen and serum creatinine), liver enzymes, cbc (complete blood count), and pt/ptt/inr (prothrombin time/partial thromboblastin time) within normal limits.
Description

Blood urea normal | Serum creatinine normal | Liver enzymes normal | Full blood count normal | Prothrombin time normal | Partial thromboplastin time normal | INR normal

Data type

boolean

Alias
UMLS CUI [1]
C0438241
UMLS CUI [2]
C0438244
UMLS CUI [3]
C0438236
UMLS CUI [4]
C0427692
UMLS CUI [5]
C0580551
UMLS CUI [6]
C0853632
UMLS CUI [7]
C0580416
voluntarily agree to participate and a sign an informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
agree to have prostate biopsy blocks provided to the study for evaluation.
Description

Biopsy of prostate Blocks Available | Block Specimens Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C1533157
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C1533157
UMLS CUI [2,2]
C1261322
agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study.
Description

Vitamin and Mineral Supplement | Avoidance Dietary Supplements Other | Avoidance Alternative medicine agent

Data type

boolean

Alias
UMLS CUI [1]
C0724359
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0242295
UMLS CUI [2,3]
C0205394
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C1626216
exclusion:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
active malignancy other than prostate cancer that requires therapy.
Description

Malignant Neoplasms Treatment required for | Exception Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600139
history of traumatic or surgical castration.
Description

Castration; traumatic | Male Castration

Data type

boolean

Alias
UMLS CUI [1]
C1392097
UMLS CUI [2]
C0007347
history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, acth, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis.
Description

Pituitary Hormone Disease | Requirement Administration of hormone Supplemental | Thyroid Hormones | ACTH | Growth Hormone | Endocrine System Diseases Requirement Administration of hormone | Exception Diabetes Mellitus | Exception Osteoporosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0032015
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0199780
UMLS CUI [2,3]
C2348609
UMLS CUI [3]
C0040135
UMLS CUI [4]
C0001655
UMLS CUI [5]
C0037663
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0199780
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0011849
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0029456
are taking certain medications. no concurrent finasteride (proscar) or other hormonal agents for chemoprevention/treatment of bph (benign prostate hyperplasia). utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted. the use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. saw palmetto, other herbal, alternative products).
Description

Finasteride | Proscar | Hormone preparation Chemoprevention Benign Prostatic Hyperplasia | Pharmaceutical Preparations Urinary obstructive symptoms Outlet of bladder | Non-Prescription Drugs Urinary tract symptoms | Saw palmetto extract | Herbal medicine (product) | Alternative medicine agent

Data type

boolean

Alias
UMLS CUI [1]
C0060389
UMLS CUI [2]
C0678149
UMLS CUI [3,1]
C0019932
UMLS CUI [3,2]
C0282515
UMLS CUI [3,3]
C1704272
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0749941
UMLS CUI [4,3]
C0447585
UMLS CUI [5,1]
C0013231
UMLS CUI [5,2]
C0476293
UMLS CUI [6]
C0771607
UMLS CUI [7]
C2240391
UMLS CUI [8]
C1626216
have certain medical conditions including: malabsorptive disorders or other metabolic disorders requiring special diet recommendations, severe constipation (may be accentuated by soy), a recent history of anemia or iron deficiency (possible accentuation by soy), or hypertension that requires a strict low sodium diet (tomato juice is high in sodium). the severity of these conditions and eligibility will be defined after careful review of the medical records by dr. clinton.
Description

Malabsorption Syndrome | Metabolic Diseases Requirement Special Diet Therapy | Severe constipation | Anemia | Iron deficiency | Hypertensive disease Requirement Low sodium diet

Data type

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0025517
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1519433
UMLS CUI [3]
C1855664
UMLS CUI [4]
C0002871
UMLS CUI [5]
C0240066
UMLS CUI [6,1]
C0020538
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0012169
have a known allergy to soy or tomato components.
Description

Allergy to soy | Allergy to tomato | Hypersensitivity Soy Component | Hypersensitivity Tomato Component

Data type

boolean

Alias
UMLS CUI [1]
C4075590
UMLS CUI [2]
C1623747
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0037733
UMLS CUI [3,3]
C1705248
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0242772
UMLS CUI [4,3]
C1705248
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Similar models

Eligibility Prostate Cancer NCT01009736

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Biopsy of prostate showed carcinoma
Item
biopsy proven carcinoma of the prostate.
boolean
C4030352 (UMLS CUI [1])
Radical prostatectomy Chosen | Radical cystoprostatectomy Chosen
Item
have chosen radical prostatectomy (or cystoprostatectomy) for treatment of their disease after presented all possible options by medical team.
boolean
C0194810 (UMLS CUI [1,1])
C1707391 (UMLS CUI [1,2])
C0194412 (UMLS CUI [2,1])
C1707391 (UMLS CUI [2,2])
Hormone Therapy Neoadjuvant Absent | Chemotherapy Neoadjuvant Absent
Item
not receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
ECOG performance status
Item
ecog (eastern cooperative oncology group) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Lycopene Absent | Soy Dietary Supplements Absent | Alternative medicine agent Absent | PC-SPES Absent | Saw palmetto extract Absent
Item
not currently taking lycopene, soy dietary supplements, or "alternative" products (i.e. pc-spes, saw palmetto).
boolean
C0065331 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0037733 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1626216 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0756934 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0771607 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Blood urea normal | Serum creatinine normal | Liver enzymes normal | Full blood count normal | Prothrombin time normal | Partial thromboplastin time normal | INR normal
Item
bun/cr (blood urea nitrogen and serum creatinine), liver enzymes, cbc (complete blood count), and pt/ptt/inr (prothrombin time/partial thromboblastin time) within normal limits.
boolean
C0438241 (UMLS CUI [1])
C0438244 (UMLS CUI [2])
C0438236 (UMLS CUI [3])
C0427692 (UMLS CUI [4])
C0580551 (UMLS CUI [5])
C0853632 (UMLS CUI [6])
C0580416 (UMLS CUI [7])
Informed Consent
Item
voluntarily agree to participate and a sign an informed consent document.
boolean
C0021430 (UMLS CUI [1])
Biopsy of prostate Blocks Available | Block Specimens Evaluation
Item
agree to have prostate biopsy blocks provided to the study for evaluation.
boolean
C0194804 (UMLS CUI [1,1])
C1533157 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C1533157 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
Vitamin and Mineral Supplement | Avoidance Dietary Supplements Other | Avoidance Alternative medicine agent
Item
agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study.
boolean
C0724359 (UMLS CUI [1])
C0870186 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0870186 (UMLS CUI [3,1])
C1626216 (UMLS CUI [3,2])
Exclusion Criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Malignant Neoplasms Treatment required for | Exception Prostate carcinoma
Item
active malignancy other than prostate cancer that requires therapy.
boolean
C0006826 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
Castration; traumatic | Male Castration
Item
history of traumatic or surgical castration.
boolean
C1392097 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
Pituitary Hormone Disease | Requirement Administration of hormone Supplemental | Thyroid Hormones | ACTH | Growth Hormone | Endocrine System Diseases Requirement Administration of hormone | Exception Diabetes Mellitus | Exception Osteoporosis
Item
history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, acth, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis.
boolean
C0032015 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0199780 (UMLS CUI [2,2])
C2348609 (UMLS CUI [2,3])
C0040135 (UMLS CUI [3])
C0001655 (UMLS CUI [4])
C0037663 (UMLS CUI [5])
C0014130 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0199780 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0011849 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0029456 (UMLS CUI [8,2])
Finasteride | Proscar | Hormone preparation Chemoprevention Benign Prostatic Hyperplasia | Pharmaceutical Preparations Urinary obstructive symptoms Outlet of bladder | Non-Prescription Drugs Urinary tract symptoms | Saw palmetto extract | Herbal medicine (product) | Alternative medicine agent
Item
are taking certain medications. no concurrent finasteride (proscar) or other hormonal agents for chemoprevention/treatment of bph (benign prostate hyperplasia). utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted. the use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. saw palmetto, other herbal, alternative products).
boolean
C0060389 (UMLS CUI [1])
C0678149 (UMLS CUI [2])
C0019932 (UMLS CUI [3,1])
C0282515 (UMLS CUI [3,2])
C1704272 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0749941 (UMLS CUI [4,2])
C0447585 (UMLS CUI [4,3])
C0013231 (UMLS CUI [5,1])
C0476293 (UMLS CUI [5,2])
C0771607 (UMLS CUI [6])
C2240391 (UMLS CUI [7])
C1626216 (UMLS CUI [8])
Malabsorption Syndrome | Metabolic Diseases Requirement Special Diet Therapy | Severe constipation | Anemia | Iron deficiency | Hypertensive disease Requirement Low sodium diet
Item
have certain medical conditions including: malabsorptive disorders or other metabolic disorders requiring special diet recommendations, severe constipation (may be accentuated by soy), a recent history of anemia or iron deficiency (possible accentuation by soy), or hypertension that requires a strict low sodium diet (tomato juice is high in sodium). the severity of these conditions and eligibility will be defined after careful review of the medical records by dr. clinton.
boolean
C0024523 (UMLS CUI [1])
C0025517 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1519433 (UMLS CUI [2,3])
C1855664 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
C0240066 (UMLS CUI [5])
C0020538 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0012169 (UMLS CUI [6,3])
Allergy to soy | Allergy to tomato | Hypersensitivity Soy Component | Hypersensitivity Tomato Component
Item
have a known allergy to soy or tomato components.
boolean
C4075590 (UMLS CUI [1])
C1623747 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0037733 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0242772 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
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