ID

19069

Beskrivning

CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00075192

Länk

https://clinicaltrials.gov/show/NCT00075192

Nyckelord

Versioner (1)
  1. 2016-12-03 2016-12-03 -
Uppladdad den

3 december 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00075192

Engelsk

Eligibility Prostatic Neoplasms NCT00075192

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate, previously untreated
Beskrivning

Adenocarcinoma of prostate untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0332155
potential candidate for radical prostatectomy on the basis of the patient's general medical condition, performance status, and life expectancy
Beskrivning

Indication Radical prostatectomy | General physical condition | performance status | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0194810
UMLS CUI [2]
C1142435
UMLS CUI [3]
C1518965
UMLS CUI [4]
C0023671
potential candidate for nht prior to prostatectomy, including high or intermediate risk of recurrence, based on an estimated risk of biochemical recurrence: high risk category: psa >20 or gleason score 8 or ct2c/ct3 or intermediate risk category: psa >10 and d20 or gleason score 7 or ct2b
Beskrivning

Indication Hormone Therapy Neoadjuvant | Prostatectomy | Recurrence Risk High | Recurrence Risk Intermediate | PSA Failure Risk Estimated | Prostate specific antigen measurement | Gleason score | TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C0600558
UMLS CUI [2]
C0033573
UMLS CUI [3,1]
C2986492
UMLS CUI [3,2]
C0205250
UMLS CUI [4,1]
C2986492
UMLS CUI [4,2]
C0205103
UMLS CUI [5,1]
C2985506
UMLS CUI [5,2]
C0035647
UMLS CUI [5,3]
C0750572
UMLS CUI [6]
C0201544
UMLS CUI [7]
C3203027
UMLS CUI [8]
C3258246
no evidence of metastatic disease by physical examination, bone scan, and computed tomography, or mri, of the abdomen and pelvis
Beskrivning

Neoplasm Metastasis Evidence of | Physical Examination Abdomen | Scan of bone Abdomen | CT of abdomen | MRI of abdomen | Physical Examination Pelvis | Scan of bone Pelvis | CT of Pelvis | MRI of Pelvis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0000726
UMLS CUI [3,1]
C0203668
UMLS CUI [3,2]
C0000726
UMLS CUI [4]
C0412620
UMLS CUI [5]
C0412693
UMLS CUI [6,1]
C0031809
UMLS CUI [6,2]
C0030797
UMLS CUI [7,1]
C0203668
UMLS CUI [7,2]
C0030797
UMLS CUI [8]
C0412628
UMLS CUI [9]
C0203201
age > 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy
Beskrivning

Bone Marrow function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
availability of prostatectomy specimen for histological analysis at the armed forces institute of pathology
Beskrivning

Prostatectomy Specimen Availability

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033573
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C0470187
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate cancer
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600139
UMLS CUI [4,1]
C0021083
UMLS CUI [4,2]
C0600139
history of, or significant risk for, chronic inflammatory or autoimmune disease
Beskrivning

Chronic inflammatory disorder Risk Significant | Autoimmune Disease Risk Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1290886
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0750502
potential requirement for systemic corticosteroids before surgery based on prior history
Beskrivning

Operative Surgical Procedures | Adrenal Cortex Hormones Systemic Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C0686904
history of autoimmune colitis or chronic gi conditions associated with diarrhea or bleeding, or current acute colitis of any origin
Beskrivning

Autoimmune colitis | Gastrointestinal Diseases chronic | Diarrhea | Hemorrhage | Colitis

Datatyp

boolean

Alias
UMLS CUI [1]
C3888552
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0011991
UMLS CUI [4]
C0019080
UMLS CUI [5]
C0009319
any serious uncontrolled medical disorder or active infection which would impair ability to receive study treatment and subsequent prostatectomy
Beskrivning

Disease Uncontrolled Serious Affecting Investigational Therapy | Communicable Disease Affecting Investigational Therapy | Disease Uncontrolled Serious Affecting Prostatectomy | Communicable Disease Affecting Prostatectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C0392760
UMLS CUI [1,5]
C0949266
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0949266
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0205404
UMLS CUI [3,4]
C0392760
UMLS CUI [3,5]
C0033573
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0033573
coexisting malignancies except basal or squamous cell carcinoma of the skin
Beskrivning

Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
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Similar models

Eligibility Prostatic Neoplasms NCT00075192

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate untreated
Item
histologically confirmed adenocarcinoma of the prostate, previously untreated
boolean
C0007112 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Indication Radical prostatectomy | General physical condition | performance status | Life Expectancy
Item
potential candidate for radical prostatectomy on the basis of the patient's general medical condition, performance status, and life expectancy
boolean
C3146298 (UMLS CUI [1,1])
C0194810 (UMLS CUI [1,2])
C1142435 (UMLS CUI [2])
C1518965 (UMLS CUI [3])
C0023671 (UMLS CUI [4])
Indication Hormone Therapy Neoadjuvant | Prostatectomy | Recurrence Risk High | Recurrence Risk Intermediate | PSA Failure Risk Estimated | Prostate specific antigen measurement | Gleason score | TNM clinical staging
Item
potential candidate for nht prior to prostatectomy, including high or intermediate risk of recurrence, based on an estimated risk of biochemical recurrence: high risk category: psa >20 or gleason score 8 or ct2c/ct3 or intermediate risk category: psa >10 and d20 or gleason score 7 or ct2b
boolean
C3146298 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,3])
C0033573 (UMLS CUI [2])
C2986492 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
C2986492 (UMLS CUI [4,1])
C0205103 (UMLS CUI [4,2])
C2985506 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0750572 (UMLS CUI [5,3])
C0201544 (UMLS CUI [6])
C3203027 (UMLS CUI [7])
C3258246 (UMLS CUI [8])
Neoplasm Metastasis Evidence of | Physical Examination Abdomen | Scan of bone Abdomen | CT of abdomen | MRI of abdomen | Physical Examination Pelvis | Scan of bone Pelvis | CT of Pelvis | MRI of Pelvis
Item
no evidence of metastatic disease by physical examination, bone scan, and computed tomography, or mri, of the abdomen and pelvis
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0000726 (UMLS CUI [2,2])
C0203668 (UMLS CUI [3,1])
C0000726 (UMLS CUI [3,2])
C0412620 (UMLS CUI [4])
C0412693 (UMLS CUI [5])
C0031809 (UMLS CUI [6,1])
C0030797 (UMLS CUI [6,2])
C0203668 (UMLS CUI [7,1])
C0030797 (UMLS CUI [7,2])
C0412628 (UMLS CUI [8])
C0203201 (UMLS CUI [9])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Prostatectomy Specimen Availability
Item
availability of prostatectomy specimen for histological analysis at the armed forces institute of pathology
boolean
C0033573 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Prostate carcinoma | Therapeutic radiology procedure Prostate carcinoma | Chemotherapy Prostate carcinoma | Immunotherapy Prostate carcinoma
Item
prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate cancer
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
C0021083 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
Chronic inflammatory disorder Risk Significant | Autoimmune Disease Risk Significant
Item
history of, or significant risk for, chronic inflammatory or autoimmune disease
boolean
C1290886 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
Operative Surgical Procedures | Adrenal Cortex Hormones Systemic Patient need for
Item
potential requirement for systemic corticosteroids before surgery based on prior history
boolean
C0543467 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Autoimmune colitis | Gastrointestinal Diseases chronic | Diarrhea | Hemorrhage | Colitis
Item
history of autoimmune colitis or chronic gi conditions associated with diarrhea or bleeding, or current acute colitis of any origin
boolean
C3888552 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0011991 (UMLS CUI [3])
C0019080 (UMLS CUI [4])
C0009319 (UMLS CUI [5])
Disease Uncontrolled Serious Affecting Investigational Therapy | Communicable Disease Affecting Investigational Therapy | Disease Uncontrolled Serious Affecting Prostatectomy | Communicable Disease Affecting Prostatectomy
Item
any serious uncontrolled medical disorder or active infection which would impair ability to receive study treatment and subsequent prostatectomy
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0949266 (UMLS CUI [1,5])
C0009450 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0205404 (UMLS CUI [3,3])
C0392760 (UMLS CUI [3,4])
C0033573 (UMLS CUI [3,5])
C0009450 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0033573 (UMLS CUI [4,3])
Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
coexisting malignancies except basal or squamous cell carcinoma of the skin
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
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