ID

15860

Description

Micro RNAs to Predict Response to Androgen Deprivation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02366494

Link

https://clinicaltrials.gov/show/NCT02366494

Keywords

  1. 6/16/16 6/16/16 -
Uploaded on

June 16, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT02366494

Eligibility Prostate Cancer NCT02366494

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven prostate cancer.
Description

prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C0600139
testosterone level >30ng/ml and at least 6 months since last dose of hormonal therapy.
Description

Testosterone measurement | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0523912
UMLS CUI [2]
C0279025
history/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration.
Description

Physical Examination | Prostate carcinoma | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0600139
UMLS CUI [3]
C3258246
ct scan of abdomen and pelvis with iv contrast and bone scan should be performed within 8 weeks prior to registration.
Description

CT with intravenous contrast Abdomen | CT with intravenous contrast Pelvis | Radioisotope scan of bone

Data type

boolean

Alias
UMLS CUI [1,1]
C0202653
UMLS CUI [1,2]
C0000726
UMLS CUI [2,1]
C0202653
UMLS CUI [2,2]
C0030797
UMLS CUI [3]
C0203668
ecog performance status 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age ≥ 18.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must provide study-specific informed consent prior to study entry for this project and mandatory blood specimen for banking for future studies (future studies may include genetic testing).
Description

Informed Consent | Blood specimen Requirement | BLOOD BANKING | Genetic testing

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0178913
UMLS CUI [2,2]
C1514873
UMLS CUI [3]
C0200495
UMLS CUI [4]
C0679560
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
received hormonal therapy less than 6 months prior to registration.
Description

Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
history of active secondary malignancy.
Description

Secondary Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C3266877
decline hormone therapy for prostate cancer.
Description

Prostate carcinoma | Hormone Therapy Refused

Data type

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1705116
current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.
Description

Therapeutic procedure 5-alpha Reductase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2936788

Similar models

Eligibility Prostate Cancer NCT02366494

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
prostate cancer
Item
histologically proven prostate cancer.
boolean
C0600139 (UMLS CUI [1])
Testosterone measurement | Hormone Therapy
Item
testosterone level >30ng/ml and at least 6 months since last dose of hormonal therapy.
boolean
C0523912 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Physical Examination | Prostate carcinoma | TNM clinical staging
Item
history/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration.
boolean
C0031809 (UMLS CUI [1])
C0600139 (UMLS CUI [2])
C3258246 (UMLS CUI [3])
CT with intravenous contrast Abdomen | CT with intravenous contrast Pelvis | Radioisotope scan of bone
Item
ct scan of abdomen and pelvis with iv contrast and bone scan should be performed within 8 weeks prior to registration.
boolean
C0202653 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0202653 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
C0203668 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≥ 18.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Blood specimen Requirement | BLOOD BANKING | Genetic testing
Item
patients must provide study-specific informed consent prior to study entry for this project and mandatory blood specimen for banking for future studies (future studies may include genetic testing).
boolean
C0021430 (UMLS CUI [1])
C0178913 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0200495 (UMLS CUI [3])
C0679560 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy
Item
received hormonal therapy less than 6 months prior to registration.
boolean
C0279025 (UMLS CUI [1])
Secondary Malignant Neoplasm
Item
history of active secondary malignancy.
boolean
C3266877 (UMLS CUI [1])
Prostate carcinoma | Hormone Therapy Refused
Item
decline hormone therapy for prostate cancer.
boolean
C0600139 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Therapeutic procedure 5-alpha Reductase Inhibitors
Item
current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.
boolean
C0087111 (UMLS CUI [1,1])
C2936788 (UMLS CUI [1,2])

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