ID

36860

Beschreibung

Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02198859

Link

https://clinicaltrials.gov/show/NCT02198859

Stichworte

Versionen (1)
  1. 17.06.19 17.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. Juni 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02198859

Englisch

Eligibility Prostate Cancer NCT02198859

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability to understand and the willingness to sign a written informed consent form.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
subjects with histologically confirmed local adenocarcinoma of the prostate who have elected to proceed with radical prostatectomy as primary curative therapy.
Beschreibung

Adenocarcinoma of prostate Local | Radical prostatectomy Curative treatment Primary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0194810
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0205225
subjects having no prior administration of lithium or lithium containing medications within 90 days of study enrollment.
Beschreibung

Lithium Absent | Absence Pharmaceutical Preparations Containing Lithium

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023870
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0023870
subjects >/= 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog (eastern cooperative oncology group) performance status of </= 1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal function defined as gfr (glomerular filtration rate) >/= 50 ml/min.
Beschreibung

Renal function | Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0017654
use of adequate contraception
Beschreibung

Use of Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
ecg (electrocardiogram) within normal limits.
Beschreibung

ECG normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522054
subjects must agree not to take any new vitamin supplements or herbal remedy during the study period.
Beschreibung

Vitamin supplement New Absent | Herbal medicine New Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681579
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C2240391
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C0332197
subjects must be able to safety take lithium carbonate for at least 4 weeks before scheduled prostatectomy.
Beschreibung

Intake Lithium Carbonate | Status pre- Prostatectomy Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0085217
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0033573
UMLS CUI [2,3]
C0205539
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have received any investigational medication within 30 days of first lithium dose.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
subjects currently receiving, or who have had previous hormonal, chemotherapy or radiotherapy for prostate cancer.
Beschreibung

Hormone Therapy Prostate carcinoma | Chemotherapy Prostate carcinoma | Therapeutic radiology procedure Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0600139
subjects with known brain metastases.
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
history of allergic reactions attributed to compounds of similar chemical or biologic composition to lithium carbonate.
Beschreibung

Allergic Reaction Compound Lithium Carbonate Similar

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0085217
UMLS CUI [1,4]
C2348205
uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
Beschreibung

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
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Ähnliche Modelle

Eligibility Prostate Cancer NCT02198859

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent form.
boolean
C0021430 (UMLS CUI [1])
Adenocarcinoma of prostate Local | Radical prostatectomy Curative treatment Primary
Item
subjects with histologically confirmed local adenocarcinoma of the prostate who have elected to proceed with radical prostatectomy as primary curative therapy.
boolean
C0007112 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0194810 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
Lithium Absent | Absence Pharmaceutical Preparations Containing Lithium
Item
subjects having no prior administration of lithium or lithium containing medications within 90 days of study enrollment.
boolean
C0023870 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0023870 (UMLS CUI [2,4])
Age
Item
subjects >/= 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog (eastern cooperative oncology group) performance status of </= 1.
boolean
C1520224 (UMLS CUI [1])
Renal function | Glomerular Filtration Rate
Item
adequate renal function defined as gfr (glomerular filtration rate) >/= 50 ml/min.
boolean
C0232804 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
Use of Contraceptive methods
Item
use of adequate contraception
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
ECG normal
Item
ecg (electrocardiogram) within normal limits.
boolean
C0522054 (UMLS CUI [1])
Vitamin supplement New Absent | Herbal medicine New Absent
Item
subjects must agree not to take any new vitamin supplements or herbal remedy during the study period.
boolean
C0681579 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C2240391 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Intake Lithium Carbonate | Status pre- Prostatectomy Scheduled
Item
subjects must be able to safety take lithium carbonate for at least 4 weeks before scheduled prostatectomy.
boolean
C1512806 (UMLS CUI [1,1])
C0085217 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0033573 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
subjects who have received any investigational medication within 30 days of first lithium dose.
boolean
C0013230 (UMLS CUI [1])
Hormone Therapy Prostate carcinoma | Chemotherapy Prostate carcinoma | Therapeutic radiology procedure Prostate carcinoma
Item
subjects currently receiving, or who have had previous hormonal, chemotherapy or radiotherapy for prostate cancer.
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain
Item
subjects with known brain metastases.
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Compound Lithium Carbonate Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to lithium carbonate.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0085217 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
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