ID

18989

Description

Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy; ODM derived from: https://clinicaltrials.gov/show/NCT00138008

Link

https://clinicaltrials.gov/show/NCT00138008

Keywords

Versions (1)
  1. 11/28/16 11/28/16 -
Uploaded on

November 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00138008

English

Eligibility Prostate Cancer NCT00138008

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of localized prostate cancer (clinical stage t1-2n0m0) which is treated by radical prostatectomy
Description

Prostate carcinoma Localized TNM clinical staging | Radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0392752
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C0194810
pathological stage: pt0/2/3 and pn0/x
Description

Pathological staging

Data type

boolean

Alias
UMLS CUI [1]
C0443276
serum level of psa once reached < 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml
Description

Prostate specific antigen measurement | Radical prostatectomy | Serum Prostate Specific Antigen Increased

Data type

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C0194810
UMLS CUI [3]
C1883014
serum level of psa 1.0 ng/ml at entry
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
no clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan
Description

Recurrence Clinical | CT of abdomen | Computed Tomography (CT) of Pelvis | scan of bone

Data type

boolean

Alias
UMLS CUI [1,1]
C0679254
UMLS CUI [1,2]
C0205210
UMLS CUI [2]
C0412620
UMLS CUI [3]
C0412628
UMLS CUI [4]
C0203668
no history of chemotherapy or radiation therapy or endocrine therapy for any cancer
Description

Chemotherapy | Therapeutic radiology procedure | Hormone Therapy Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0006826
ages 20 to 79 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
no blood transfusion within 28 days of entry
Description

Blood Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0005841
sufficient organ function within 28 days of entry
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
provided written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
Description

Malignant Neoplasm Synchronous | Metachronous Malignant Neoplasm | Carcinoma in Situ

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0439580
UMLS CUI [2]
C1334703
UMLS CUI [3]
C0007099
mental disease or mental symptoms which would affect participant's decision to participate
Description

Mental disorder Affecting Study Subject Participation Status | Psychiatric symptom Affecting Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0233401
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C2348568
continuous medication with steroids (exclude external use of steroids for skin)
Description

Steroids | Steroids External use Skin

Data type

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0521134
UMLS CUI [2,3]
C1123023
ischemic heart disease or arrhythmia which needs medical treatment
Description

Myocardial Ischemia Requirement Therapeutic procedure | Cardiac Arrhythmia Requirement Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0087111
poorly controlled hypertension
Description

Poor hypertension control

Data type

boolean

Alias
UMLS CUI [1]
C0421190
poorly controlled diabetes mellitus
Description

Diabetes mellitus poor control

Data type

boolean

Alias
UMLS CUI [1]
C0860161
history of cerebral infarction or myocardial infarction within 6 months
Description

Cerebral Infarction | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0007785
UMLS CUI [2]
C0027051
liver cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine
Description

Interstitial Pneumonia Requirement Assisted breathing | Interstitial Pneumonia Requirement Oxygen Therapy Care | Interstitial Pneumonia Requirement Steroids | Interstitial Pneumonia Requirement Diuretics

Data type

boolean

Alias
UMLS CUI [1,1]
C0206061
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0554804
UMLS CUI [2,1]
C0206061
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0184633
UMLS CUI [3,1]
C0206061
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0038317
UMLS CUI [4,1]
C0206061
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0012798
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Similar models

Eligibility Prostate Cancer NCT00138008

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma Localized TNM clinical staging | Radical prostatectomy
Item
a diagnosis of localized prostate cancer (clinical stage t1-2n0m0) which is treated by radical prostatectomy
boolean
C0600139 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0194810 (UMLS CUI [2])
Pathological staging
Item
pathological stage: pt0/2/3 and pn0/x
boolean
C0443276 (UMLS CUI [1])
Prostate specific antigen measurement | Radical prostatectomy | Serum Prostate Specific Antigen Increased
Item
serum level of psa once reached < 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml
boolean
C0201544 (UMLS CUI [1])
C0194810 (UMLS CUI [2])
C1883014 (UMLS CUI [3])
Prostate specific antigen measurement
Item
serum level of psa 1.0 ng/ml at entry
boolean
C0201544 (UMLS CUI [1])
Recurrence Clinical | CT of abdomen | Computed Tomography (CT) of Pelvis | scan of bone
Item
no clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan
boolean
C0679254 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0412620 (UMLS CUI [2])
C0412628 (UMLS CUI [3])
C0203668 (UMLS CUI [4])
Chemotherapy | Therapeutic radiology procedure | Hormone Therapy Malignant Neoplasms
Item
no history of chemotherapy or radiation therapy or endocrine therapy for any cancer
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
Age
Item
ages 20 to 79 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Blood Transfusion
Item
no blood transfusion within 28 days of entry
boolean
C0005841 (UMLS CUI [1])
organ function
Item
sufficient organ function within 28 days of entry
boolean
C0678852 (UMLS CUI [1])
Informed Consent
Item
provided written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm Synchronous | Metachronous Malignant Neoplasm | Carcinoma in Situ
Item
synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
boolean
C0006826 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C1334703 (UMLS CUI [2])
C0007099 (UMLS CUI [3])
Mental disorder Affecting Study Subject Participation Status | Psychiatric symptom Affecting Study Subject Participation Status
Item
mental disease or mental symptoms which would affect participant's decision to participate
boolean
C0004936 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0233401 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Steroids | Steroids External use Skin
Item
continuous medication with steroids (exclude external use of steroids for skin)
boolean
C0038317 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0521134 (UMLS CUI [2,2])
C1123023 (UMLS CUI [2,3])
Myocardial Ischemia Requirement Therapeutic procedure | Cardiac Arrhythmia Requirement Therapeutic procedure
Item
ischemic heart disease or arrhythmia which needs medical treatment
boolean
C0151744 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Poor hypertension control
Item
poorly controlled hypertension
boolean
C0421190 (UMLS CUI [1])
Diabetes mellitus poor control
Item
poorly controlled diabetes mellitus
boolean
C0860161 (UMLS CUI [1])
Cerebral Infarction | Myocardial Infarction
Item
history of cerebral infarction or myocardial infarction within 6 months
boolean
C0007785 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Liver Cirrhosis
Item
liver cirrhosis
boolean
C0023890 (UMLS CUI [1])
Interstitial Pneumonia Requirement Assisted breathing | Interstitial Pneumonia Requirement Oxygen Therapy Care | Interstitial Pneumonia Requirement Steroids | Interstitial Pneumonia Requirement Diuretics
Item
interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine
boolean
C0206061 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0554804 (UMLS CUI [1,3])
C0206061 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0184633 (UMLS CUI [2,3])
C0206061 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0038317 (UMLS CUI [3,3])
C0206061 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0012798 (UMLS CUI [4,3])
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