ID

36888

Beschreibung

Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC); ODM derived from: https://clinicaltrials.gov/show/NCT02380274

Link

https://clinicaltrials.gov/show/NCT02380274

Stichworte

Versionen (1)
  1. 18.06.19 18.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. Juni 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02380274

Englisch

Eligibility Prostate Cancer NCT02380274

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient inclusion:
Beschreibung

Patient Inclusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512693
confirmed diagnosis of crpc (defined by a minimum of two rising psa levels to be measured at least 7 days apart, and serum testosterone level ≤ 1.73 nmol/l (50 ng/dl) or with new evidence of metastatic disease by investigating physician
Beschreibung

Hormone refractory prostate cancer | Raised prostate specific antigen Quantity | Serum testosterone measurement | Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0428413
UMLS CUI [4]
C0027627
initiating the first active course of anti-cancer treatment for m0 crpc or for m1 crpc (regardless of prior m0 crpc treatment) such as anti-androgens, androgen synthesis inhibitors, chemotherapy, immunotherapy or radionuclide therapy. patients may be enrolled within 45 days from the time of treatment initiation.
Beschreibung

Cancer treatment Hormone refractory prostate cancer TNM clinical staging | Androgen Antagonists | Androgen Synthesis Inhibitors | Chemotherapy | Immunotherapy | Radionuclide therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1328504
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C0002842
UMLS CUI [3]
C3853002
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0203608
willing and able to complete periodic patient-reported outcome (pro) questionnaires, with or without assistance
Beschreibung

Patient Reported Outcome Completion Assisted | Patient Reported Outcome Completion Unaided

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2987124
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1269765
UMLS CUI [2,1]
C2987124
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0439846
estimated life expectancy of ≥ 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
caregiver inclusion:
Beschreibung

Caregiver Inclusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C1512693
meets the definition of an unpaid relative or friend who helps the patient with his or her activities of daily living
Beschreibung

Patient Assistance Activities of Daily Living

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1269765
UMLS CUI [1,3]
C0001288
willing and able to complete caregiver-reported outcome questionnaires over the course of the patient's participation in the study
Beschreibung

Caregiver Reported Outcome Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C4319718
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C0205197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient exclusion:
Beschreibung

Patient Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0680251
currently enrolled in any interventional clinical trial with a non-approved investigational agent for the primary disease of crpc at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the study)
Beschreibung

Study Subject Participation Status | Interventional Study | Investigational New Drugs Hormone refractory prostate cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1328504
receiving concomitant treatment for other cancer (excluding basal cell carcinoma and treatment for hormone sensitive prostate cancer) within 6 months prior to enrollment.
Beschreibung

Treatment Cancer Other | Exception Basal cell carcinoma | Exception Hormone sensitive prostate cancer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C4302896
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Ähnliche Modelle

Eligibility Prostate Cancer NCT02380274

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Patient Inclusion
Item
patient inclusion:
boolean
C0030705 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Hormone refractory prostate cancer | Raised prostate specific antigen Quantity | Serum testosterone measurement | Neoplasm Metastasis
Item
confirmed diagnosis of crpc (defined by a minimum of two rising psa levels to be measured at least 7 days apart, and serum testosterone level ≤ 1.73 nmol/l (50 ng/dl) or with new evidence of metastatic disease by investigating physician
boolean
C1328504 (UMLS CUI [1])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0428413 (UMLS CUI [3])
C0027627 (UMLS CUI [4])
Cancer treatment Hormone refractory prostate cancer TNM clinical staging | Androgen Antagonists | Androgen Synthesis Inhibitors | Chemotherapy | Immunotherapy | Radionuclide therapy
Item
initiating the first active course of anti-cancer treatment for m0 crpc or for m1 crpc (regardless of prior m0 crpc treatment) such as anti-androgens, androgen synthesis inhibitors, chemotherapy, immunotherapy or radionuclide therapy. patients may be enrolled within 45 days from the time of treatment initiation.
boolean
C0920425 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0002842 (UMLS CUI [2])
C3853002 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0203608 (UMLS CUI [6])
Patient Reported Outcome Completion Assisted | Patient Reported Outcome Completion Unaided
Item
willing and able to complete periodic patient-reported outcome (pro) questionnaires, with or without assistance
boolean
C2987124 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1269765 (UMLS CUI [1,3])
C2987124 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0439846 (UMLS CUI [2,3])
Life Expectancy
Item
estimated life expectancy of ≥ 6 months
boolean
C0023671 (UMLS CUI [1])
Caregiver Inclusion
Item
caregiver inclusion:
boolean
C0085537 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Patient Assistance Activities of Daily Living
Item
meets the definition of an unpaid relative or friend who helps the patient with his or her activities of daily living
boolean
C0030705 (UMLS CUI [1,1])
C1269765 (UMLS CUI [1,2])
C0001288 (UMLS CUI [1,3])
Caregiver Reported Outcome Completion
Item
willing and able to complete caregiver-reported outcome questionnaires over the course of the patient's participation in the study
boolean
C0085537 (UMLS CUI [1,1])
C4319718 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Patient Exclusion Criteria
Item
patient exclusion:
boolean
C0030705 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Study Subject Participation Status | Interventional Study | Investigational New Drugs Hormone refractory prostate cancer
Item
currently enrolled in any interventional clinical trial with a non-approved investigational agent for the primary disease of crpc at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the study)
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C1328504 (UMLS CUI [3,2])
Treatment Cancer Other | Exception Basal cell carcinoma | Exception Hormone sensitive prostate cancer
Item
receiving concomitant treatment for other cancer (excluding basal cell carcinoma and treatment for hormone sensitive prostate cancer) within 6 months prior to enrollment.
boolean
C0087111 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C4302896 (UMLS CUI [3,2])
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