ID

29440

Description

Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01050504

Link

https://clinicaltrials.gov/show/NCT01050504

Keywords

Versions (1)
  1. 3/24/18 3/24/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 24, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Healthy Control NCT01050504

English

Eligibility Healthy Control NCT01050504

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured
Description

Carcinoma of bladder Localized | Metastatic Neoplasm to the Bladder | Cancer of Urinary Tract Localized | Cancer of Urinary Tract metastatic | Prostate carcinoma Localized | Secondary malignant neoplasm of prostate | Disease Organ Primary | Secondary malignant neoplasm of bone eligible | Secondary malignant neoplasm of soft tissues eligible | Transurethral Resection of Prostate | Transurethral bladder excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0699885
UMLS CUI [1,2]
C0392752
UMLS CUI [2]
C0347011
UMLS CUI [3,1]
C0751571
UMLS CUI [3,2]
C0392752
UMLS CUI [4,1]
C0751571
UMLS CUI [4,2]
C1522484
UMLS CUI [5,1]
C0600139
UMLS CUI [5,2]
C0392752
UMLS CUI [6]
C0347001
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C0178784
UMLS CUI [7,3]
C0205225
UMLS CUI [8,1]
C0153690
UMLS CUI [8,2]
C1548635
UMLS CUI [9,1]
C0684686
UMLS CUI [9,2]
C1548635
UMLS CUI [10]
C0040771
UMLS CUI [11]
C0565251
ability to adequately understand and give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications
Description

Disorder of soft tissue Local | Disorder of soft tissue metastatic | Bone Disease Local | Bone Disease metastatic | Site Biopsy Possible | Complication Risk Minimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0263978
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0263978
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0005940
UMLS CUI [3,2]
C0205276
UMLS CUI [4,1]
C0005940
UMLS CUI [4,2]
C1522484
UMLS CUI [5,1]
C1515974
UMLS CUI [5,2]
C0005558
UMLS CUI [5,3]
C0332149
UMLS CUI [6,1]
C0009566
UMLS CUI [6,2]
C0035647
UMLS CUI [6,3]
C0547040
platelet count > 50,000
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
white blood cell (wbc) > 1,500
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
hemoglobin (hgb) > 8.0
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
international normalized ratio (inr) < 1.5
Description

International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0525032
partial thromboplastin time (ptt) < 45
Description

Partial Thromboplastin Time measurement

Data type

boolean

Alias
UMLS CUI [1]
C0030605
no history of excessive unexplained bleeding from previous surgery
Description

Absence Prolonged bleeding after surgery Etiology Unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C4021646
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0439673
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients unable to stop chronic anticoagulation with warfarin or lovenox for less than 3 days
Description

Chronic anticoagulation Unable to discontinue | Warfarin Unable to discontinue | Lovenox Unable to discontinue

Data type

boolean

Alias
UMLS CUI [1,1]
C0694554
UMLS CUI [1,2]
C1548265
UMLS CUI [2,1]
C0043031
UMLS CUI [2,2]
C1548265
UMLS CUI [3,1]
C0728963
UMLS CUI [3,2]
C1548265
serious or uncontrolled infection
Description

Communicable Disease Serious | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
treatment with a vascular endothelial growth factor (vegf) inhibitor (such as avastin) within the past 28 days
Description

Vascular Endothelial Growth Factor Inhibitors | Avastin

Data type

boolean

Alias
UMLS CUI [1]
C2267120
UMLS CUI [2]
C1135130
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Similar models

Eligibility Healthy Control NCT01050504

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma of bladder Localized | Metastatic Neoplasm to the Bladder | Cancer of Urinary Tract Localized | Cancer of Urinary Tract metastatic | Prostate carcinoma Localized | Secondary malignant neoplasm of prostate | Disease Organ Primary | Secondary malignant neoplasm of bone eligible | Secondary malignant neoplasm of soft tissues eligible | Transurethral Resection of Prostate | Transurethral bladder excision
Item
patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured
boolean
C0699885 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C0347011 (UMLS CUI [2])
C0751571 (UMLS CUI [3,1])
C0392752 (UMLS CUI [3,2])
C0751571 (UMLS CUI [4,1])
C1522484 (UMLS CUI [4,2])
C0600139 (UMLS CUI [5,1])
C0392752 (UMLS CUI [5,2])
C0347001 (UMLS CUI [6])
C0012634 (UMLS CUI [7,1])
C0178784 (UMLS CUI [7,2])
C0205225 (UMLS CUI [7,3])
C0153690 (UMLS CUI [8,1])
C1548635 (UMLS CUI [8,2])
C0684686 (UMLS CUI [9,1])
C1548635 (UMLS CUI [9,2])
C0040771 (UMLS CUI [10])
C0565251 (UMLS CUI [11])
Informed Consent
Item
ability to adequately understand and give informed consent
boolean
C0021430 (UMLS CUI [1])
Disorder of soft tissue Local | Disorder of soft tissue metastatic | Bone Disease Local | Bone Disease metastatic | Site Biopsy Possible | Complication Risk Minimal
Item
local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications
boolean
C0263978 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0263978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0005940 (UMLS CUI [3,1])
C0205276 (UMLS CUI [3,2])
C0005940 (UMLS CUI [4,1])
C1522484 (UMLS CUI [4,2])
C1515974 (UMLS CUI [5,1])
C0005558 (UMLS CUI [5,2])
C0332149 (UMLS CUI [5,3])
C0009566 (UMLS CUI [6,1])
C0035647 (UMLS CUI [6,2])
C0547040 (UMLS CUI [6,3])
Platelet Count measurement
Item
platelet count > 50,000
boolean
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood cell (wbc) > 1,500
boolean
C0023508 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin (hgb) > 8.0
boolean
C0518015 (UMLS CUI [1])
International Normalized Ratio
Item
international normalized ratio (inr) < 1.5
boolean
C0525032 (UMLS CUI [1])
Partial Thromboplastin Time measurement
Item
partial thromboplastin time (ptt) < 45
boolean
C0030605 (UMLS CUI [1])
Absence Prolonged bleeding after surgery Etiology Unknown
Item
no history of excessive unexplained bleeding from previous surgery
boolean
C0332197 (UMLS CUI [1,1])
C4021646 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Chronic anticoagulation Unable to discontinue | Warfarin Unable to discontinue | Lovenox Unable to discontinue
Item
patients unable to stop chronic anticoagulation with warfarin or lovenox for less than 3 days
boolean
C0694554 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0043031 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
C0728963 (UMLS CUI [3,1])
C1548265 (UMLS CUI [3,2])
Communicable Disease Serious | Communicable Disease Uncontrolled
Item
serious or uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Vascular Endothelial Growth Factor Inhibitors | Avastin
Item
treatment with a vascular endothelial growth factor (vegf) inhibitor (such as avastin) within the past 28 days
boolean
C2267120 (UMLS CUI [1])
C1135130 (UMLS CUI [2])
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