ID

31592

Beschrijving

Selenomethionine in Treating Patients Undergoing Surgery or Internal Radiation Therapy for Stage I or Stage II Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00736164

Link

https://clinicaltrials.gov/show/NCT00736164

Trefwoorden

Versies (2)
  1. 09-09-18 09-09-18 -
  2. 10-09-18 10-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 september 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Prostate Cancer NCT00736164

Engels

Eligibility Prostate Cancer NCT00736164

1 Formulieren  
Criteria
Beschrijving

Criteria

histologically confirmed adenocarcinoma of the prostate
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
diagnosed by sextant or greater biopsy
Beschrijving

Diagnosis Sextant biopsy | Diagnosis Biopsy Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C3846092
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C1265611
clinical stage t1a-t2c disease
Beschrijving

Disease TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
gleason score < 8
Beschrijving

Gleason score

Datatype

boolean

Alias
UMLS CUI [1]
C3203027
prostate-specific antigen < 20.0 ng/ml
Beschrijving

Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
scheduled to undergo prostatectomy or brachytherapy
Beschrijving

Prostatectomy Scheduled | Brachytherapy Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033573
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0006098
UMLS CUI [2,2]
C0205539
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
life expectancy > 5 years
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
no other prior malignancy except nonmelanoma skin cancer
Beschrijving

Exclusion | Cancer Other | Exception Skin carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C1707251
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
willing to take selenomethionine or placebo for 8-9 weeks immediately prior to undergoing prostatectomy or brachytherapy
Beschrijving

Selenomethionine | Placebo | Status pre- Prostatectomy | Status pre- Brachytherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0036584
UMLS CUI [2]
C1696465
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0033573
UMLS CUI [4,1]
C0332152
UMLS CUI [4,2]
C0006098
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
no prior hormonal therapy or radiotherapy
Beschrijving

Exclusion Criteria | Hormone Therapy | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0279025
UMLS CUI [3]
C1522449
more than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or lifestyle intervention (e.g., dietary modification or exercise)
Beschrijving

Exclusion Criteria | Study Subject Participation Status Involving Therapeutic intervention | Study Subject Participation Status Involving Surgical intervention | Study Subject Participation Status Involving Nutritional Intervention | Study Subject Participation Status Involving Life Style Intervention | Dietary Modification | Exercise

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0549433
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C1882127
UMLS CUI [5,1]
C2348568
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C0023676
UMLS CUI [5,4]
C0184661
UMLS CUI [6]
C0086153
UMLS CUI [7]
C0015259
no concurrent dietary supplementation with selenium at doses > 60 mcg/day, including multivitamin supplements
Beschrijving

Exclusion Criteria | Selenium supplement Dose U/day | Multivitamin Supplements

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0521939
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0301532
UMLS CUI [3,2]
C0242295
no concurrent hormonal therapy, including 5-alpha reductase inhibitors (e.g., finasteride or dutasteride); anti-androgens (e.g., bicalutamide, flutamide, or ketoconazole); or luteinizing hormone-releasing hormone agonists (e.g., leuprolide acetate, goserelin acetate, or abarelix)
Beschrijving

Exclusion Criteria | Hormone Therapy | 5-alpha Reductase Inhibitors | Finasteride | Dutasteride | Androgen Antagonists | bicalutamide | Flutamide | Ketoconazole | Luteinizing Hormone-releasing Hormone Agonist | Leuprolide Acetate | Goserelin Acetate | abarelix

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0279025
UMLS CUI [3]
C2936788
UMLS CUI [4]
C0060389
UMLS CUI [5]
C0754659
UMLS CUI [6]
C0002842
UMLS CUI [7]
C0285590
UMLS CUI [8]
C0016384
UMLS CUI [9]
C0022625
UMLS CUI [10]
C1518041
UMLS CUI [11]
C0700596
UMLS CUI [12]
C0700476
UMLS CUI [13]
C0965390
Terug naar het begin van de pagina

Similar models

Eligibility Prostate Cancer NCT00736164

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Diagnosis Sextant biopsy | Diagnosis Biopsy Quantity
Item
diagnosed by sextant or greater biopsy
boolean
C0011900 (UMLS CUI [1,1])
C3846092 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Disease TNM clinical staging
Item
clinical stage t1a-t2c disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Gleason score
Item
gleason score < 8
boolean
C3203027 (UMLS CUI [1])
Prostate specific antigen measurement
Item
prostate-specific antigen < 20.0 ng/ml
boolean
C0201544 (UMLS CUI [1])
Prostatectomy Scheduled | Brachytherapy Scheduled
Item
scheduled to undergo prostatectomy or brachytherapy
boolean
C0033573 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0006098 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 5 years
boolean
C0023671 (UMLS CUI [1])
Exclusion | Cancer Other | Exception Skin carcinoma
Item
no other prior malignancy except nonmelanoma skin cancer
boolean
C2828389 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Selenomethionine | Placebo | Status pre- Prostatectomy | Status pre- Brachytherapy
Item
willing to take selenomethionine or placebo for 8-9 weeks immediately prior to undergoing prostatectomy or brachytherapy
boolean
C0036584 (UMLS CUI [1])
C1696465 (UMLS CUI [2])
C0332152 (UMLS CUI [3,1])
C0033573 (UMLS CUI [3,2])
C0332152 (UMLS CUI [4,1])
C0006098 (UMLS CUI [4,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Exclusion Criteria | Hormone Therapy | Therapeutic radiology procedure
Item
no prior hormonal therapy or radiotherapy
boolean
C0680251 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Exclusion Criteria | Study Subject Participation Status Involving Therapeutic intervention | Study Subject Participation Status Involving Surgical intervention | Study Subject Participation Status Involving Nutritional Intervention | Study Subject Participation Status Involving Life Style Intervention | Dietary Modification | Exercise
Item
more than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or lifestyle intervention (e.g., dietary modification or exercise)
boolean
C0680251 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C2348568 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0549433 (UMLS CUI [3,3])
C2348568 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C1882127 (UMLS CUI [4,3])
C2348568 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0023676 (UMLS CUI [5,3])
C0184661 (UMLS CUI [5,4])
C0086153 (UMLS CUI [6])
C0015259 (UMLS CUI [7])
Exclusion Criteria | Selenium supplement Dose U/day | Multivitamin Supplements
Item
no concurrent dietary supplementation with selenium at doses > 60 mcg/day, including multivitamin supplements
boolean
C0680251 (UMLS CUI [1])
C0521939 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0301532 (UMLS CUI [3,1])
C0242295 (UMLS CUI [3,2])
Exclusion Criteria | Hormone Therapy | 5-alpha Reductase Inhibitors | Finasteride | Dutasteride | Androgen Antagonists | bicalutamide | Flutamide | Ketoconazole | Luteinizing Hormone-releasing Hormone Agonist | Leuprolide Acetate | Goserelin Acetate | abarelix
Item
no concurrent hormonal therapy, including 5-alpha reductase inhibitors (e.g., finasteride or dutasteride); anti-androgens (e.g., bicalutamide, flutamide, or ketoconazole); or luteinizing hormone-releasing hormone agonists (e.g., leuprolide acetate, goserelin acetate, or abarelix)
boolean
C0680251 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C2936788 (UMLS CUI [3])
C0060389 (UMLS CUI [4])
C0754659 (UMLS CUI [5])
C0002842 (UMLS CUI [6])
C0285590 (UMLS CUI [7])
C0016384 (UMLS CUI [8])
C0022625 (UMLS CUI [9])
C1518041 (UMLS CUI [10])
C0700596 (UMLS CUI [11])
C0700476 (UMLS CUI [12])
C0965390 (UMLS CUI [13])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial